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Comparative Analysis Using the Collagen Matrix and Autogenous Graft: Clinical Course, Aesthetic Results

Primary Purpose

Soft Tissue Atrophy

Status
Active
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Soft tissue augmentation with CTG
Soft tissue augmentation with CM
Sponsored by
I.M. Sechenov First Moscow State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft Tissue Atrophy focused on measuring Connective tissue graft, xenogeic collagen matrix, increasing of soft tissue thickness, dental implant, soft tissue augmentation

Eligibility Criteria

25 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The presence of written informed consent of the patient to participate in the study; Age from 25 to 59 years; The presence of an included defect in the distal part of the lower jaw with a sufficient volume of bone tissue; Soft tissue thickness <3 mm on the vestibular side; Adjacent teeth without periodontal pathology, the depth of probing should not exceed 3 mm along the entire dentoalveolar furrow; Satisfactory level of oral hygiene; Patients without concomitant pathology or with concomitant pathology in the compensation stage. Non-inclusion criteria: Age less than 25 and more than 59 years; Hard smokers (more than 10 cigarettes a day); The presence of concomitant pathology in the stage of decompensation; Patients with malignant tumors, as well as patients with a history of radiation and chemotherapy over the past 5 years; Taking medications that affect the healing of soft tissues (nonsteroidal anti-inflammatory drugs, steroid drugs); Pregnancy and breastfeeding; Patients with mental disorders. Exclusion Criteria: Patients with infections either periodontally or periapically, which developed after inclusion in the study; Pregnancy following entrance into the study; Patients having poor oral hygiene or not wanting to carry out oral hygiene measures; Patients who, for one reason or another, could not complete the entire protocol to the end.

Sites / Locations

  • I.M. Sechenov First Moscow State Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

First group

Second group

Arm Description

The patients underwent implant placement in combination with an increase in the thickness of soft tissues using a free connective tissue graft from the tuberosity area of the upper jaw

The patients underwent implant placement in combination with an increase in the thickness of soft tissues using collagen matrix "Fibro-Gide"

Outcomes

Primary Outcome Measures

The amount of soft tissue thickness gain
The value of soft tissue thickness gain in the study area (mm) on the 90th day compared to the 0th day (initial value).To carry out the measurement an optical impression was taken using the Primescan intraoral scanner (Dentsply/SIRONA,Germany, 16.05.2019, № RD-27221/26851) before the operation and on the 90th day after the operation. Further, in the specialized program GOM Inspect the stl-files were compared and the vestibular contour changes were evaluated at 3 equidistant points in the coronary-apical direction. The мean value between the points was the amount of soft tissue thickness gain (mm).

Secondary Outcome Measures

The amount of soft tissue thickness gain
The value of soft tissue thickness gain in the study area (mm) on the 180th day compared to the 0th day (initial value).To carry out the measurement an optical impression was taken using the Primescan intraoral scanner (Dentsply/SIRONA,Germany, 16.05.2019, № RD-27221/26851) before the operation and on the 180th day after the operation. Further, in the specialized program GOM Inspect the stl-files were compared and the vestibular contour changes were evaluated at 3 equidistant points in the coronary-apical direction. The мean value between the points was the amount of soft tissue thickness gain (mm).
Assessment of the severity of pain syndrome
Visual Analogue Scale (VAS). Evaluation of the severity of pain syndrome was carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain.
Assessment of the severity of pain syndrome
Visual Analogue Scale (VAS). Evaluation of the severity of pain syndrome was carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain.
Assessment of the severity of pain syndrome
Visual Analogue Scale (VAS). Evaluation of the severity of pain syndrome was carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain.
Assessment of the severity of pain syndrome
Visual Analogue Scale (VAS). Evaluation of the severity of pain syndrome was carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain.
Assessment of the severity of pain syndrome
Visual Analogue Scale (VAS). Evaluation of the severity of pain syndrome was carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain.
Assessment of the severity of pain syndrome
Visual Analogue Scale (VAS). Evaluation of the severity of pain syndrome was carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain.
Assessment of the collateral edema
Edema was clinically assessed by its volume (scores 0-2; 0 points - no edema, 1 point - moderate edema, 2 points - intense edema compared to the condition of adjacent tissues).
Assessment of the collateral edema
Edema was clinically assessed by its volume (scores 0-2; 0 points - no edema, 1 point - moderate edema, 2 points - intense edema compared to the condition of adjacent tissues).
Assessment of the collateral edema
Edema was clinically assessed by its volume (scores 0-2; 0 points - no edema, 1 point - moderate edema, 2 points - intense edema compared to the condition of adjacent tissues).
Assessment of the collateral edema
Edema was clinically assessed by its volume (scores 0-2; 0 points - no edema, 1 point - moderate edema, 2 points - intense edema compared to the condition of adjacent tissues).
Assessment of consumption of analgesics
Patients' analgesic consumption was assessed by estimating the number of packs of Nimesulide (100 mg) taken.
Assessment of consumption of analgesics
Patients' analgesic consumption was assessed by estimating the number of packs of Nimesulide (100 mg) taken.
Assessment of consumption of analgesics
Patients' analgesic consumption was assessed by estimating the number of packs of Nimesulide (100 mg) taken.
Assessment of consumption of analgesics
Patients' analgesic consumption was assessed by estimating the number of packs of Nimesulide (100 mg) taken.
Assessment of the quality of life
The patient's quality of life was assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. The questionnaire consists of 14 questions that provide patient's self-reported measure of dysfunction, discomfort and disability arising from oral conditions. Each question is scored on a 5-point scale: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = fairly often; 4 = very often/every day. The OHIP-14 total score can range from 0 to 56. Higher OHIP-14 scores indicate worse quality of life and lower scores indicate better quality of life.
Assessment of the quality of life
The patient's quality of life was assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. The questionnaire consists of 14 questions that provide patient's self-reported measure of dysfunction, discomfort and disability arising from oral conditions. Each question is scored on a 5-point scale: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = fairly often; 4 = very often/every day. The OHIP-14 total score can range from 0 to 56. Higher OHIP-14 scores indicate worse quality of life and lower scores indicate better quality of life.
Assessment of the quality of life
The patient's quality of life was assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. The questionnaire consists of 14 questions that provide patient's self-reported measure of dysfunction, discomfort and disability arising from oral conditions. Each question is scored on a 5-point scale: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = fairly often; 4 = very often/every day. The OHIP-14 total score can range from 0 to 56. Higher OHIP-14 scores indicate worse quality of life and lower scores indicate better quality of life.
Attached mucosa measurement
The width of the keratinised attached mucosa was measured using the UNC-15 periodontal probe. This was done by determining the mucosa-gingival junction line on the vestibular side. The distance from this line to the apex of the alveolar ridge was correspond to the width of the keratinised attached mucosa.
Attached mucosa measurement
The width of the keratinised attached mucosa was measured using the UNC-15 periodontal probe. This was done by determining the mucosa-gingival junction line on the vestibular side. The distance from this line to the apex of the alveolar ridge was correspond to the width of the keratinised attached mucosa.
Attached mucosa measurement
The width of the keratinised attached mucosa was measured using the UNC-15 periodontal probe. This was done by determining the mucosa-gingival junction line on the vestibular side. The distance from this line to the apex of the alveolar ridge was correspond to the width of the keratinised attached mucosa.
Soft tissue aesthetics
Evaluation of soft tissue aesthetics was carried out by visual inspection taking into account the PES (pink aesthetic score). The evaluation was carried out according to a score of 0-1-2, where 0 was the lowest value and 2 was the highest, the maximum achievable PES value was 14.

Full Information

First Posted
April 25, 2023
Last Updated
May 12, 2023
Sponsor
I.M. Sechenov First Moscow State Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05870774
Brief Title
Comparative Analysis Using the Collagen Matrix and Autogenous Graft: Clinical Course, Aesthetic Results
Official Title
Soft Tissue Augmentation Around Implants With Collagen Matrix and Autogenous Graft: 6-months Prospective Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 28, 2021 (Actual)
Primary Completion Date
December 25, 2022 (Actual)
Study Completion Date
May 18, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
I.M. Sechenov First Moscow State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This was an interventional prospective randomized clinical trial (RCT) in parallel groups. The sample size is 32 patients who were randomly divided into two groups depending on the surgical intervention used. First group - patients underwent increasing the thickness of the mucous membrane using free connective tissue graft from tuberosity area of the upper jaw. Second group - patients used collagen matrix Fibro-Gide" (Geistlich Pharma AG, Bahnhofstrasse 40, 6110 Wolhusen, Switzerland; registration in Russia 19.08.2020 No FSZ -20207/11765). In the postoperative period the value of soft tissue thickness gain, severity of pain, collateral edema, amount of analgesics consumed, soft tissue aesthetics, keratinized mucosa width, quality of life and duration of surgery were assessed.
Detailed Description
The aim of this research was to perform a comparative clinical analysis of soft tissues in the area of soft tissue graft and collagen matrix transplantation. Thirty two patients diagnosed with partial absence of teeth was examined on the basis of the Department of Surgical Dentistry of the E.V. Borovsky Institute of Dentistry of I.M. Sechenov First Moscow State Medical University. Patients had a soft tissue thickness deficiency from the vestibular surface in the area of the planned dental implant placement in the distal parts of the mandible, which was an indication for its increase. All patients were randomly divided into two groups depending on method of soft tissue augmentation used. In 1 group (n=16) transplantation of a free connective tissue graft (CTG) from tuberosity area of the upper jaw was performed. In 2 group (n=16) collagen matrix "Fibro-Gide" was used. According to gender and age characteristics, both groups were comparable. Randomization of patients was carried out at the stage of surgical intervention as follows: after a dental implant placement and preparation of recipient's bed, an envelope with a randomly assigned treatment method (using a connective tissue graft or a collagen matrix) was opened. During the operation, incision was made along the top of the alveolar ridge within the defect; a full-thickness muco-periosteal flap was elevated. Traditional 2-stage dental implantation was performed according to surgical protocols of dental implant systems Astra Tech (Dentsply Implants Manufacturing GmbH, Germany; registration in Russia 27.12.2019 No FSZ 2015/3214). A free connective tissue graft was harvested in patients of the first group. Graft was fixed with a horizontal U-shaped suture to the buccal muco-periosteal flap. In second patients group a fragment of the collagen matrix "Fibro-Gide" was fixed to the buccal muco-periosteal flap (Geistlich Pharma AG, Bahnhofstrasse 40, 6110 Wolhusen, Switzerland; registration in Russia 19.08.2020 No FSZ - 20207/11765). For patients of all groups mobilization of the muco-periosteal flap conducted followed by suturing the wound tightly without tension with simple interrupted sutures. Postoperative recommendations included standard antibacterial and anti-inflammatory therapy in combination with the use of local antiseptics for daily care was prescribed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Atrophy
Keywords
Connective tissue graft, xenogeic collagen matrix, increasing of soft tissue thickness, dental implant, soft tissue augmentation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
First group
Arm Type
Active Comparator
Arm Description
The patients underwent implant placement in combination with an increase in the thickness of soft tissues using a free connective tissue graft from the tuberosity area of the upper jaw
Arm Title
Second group
Arm Type
Experimental
Arm Description
The patients underwent implant placement in combination with an increase in the thickness of soft tissues using collagen matrix "Fibro-Gide"
Intervention Type
Procedure
Intervention Name(s)
Soft tissue augmentation with CTG
Intervention Description
Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation Placement of the Astra Tech dental implant (Dentsply, Germany) Harvesting of free connective tissue graft from the maxilla tuberosity area Fixation of the graft to the vestibular mucosal-periosteal flap Suturing the wound tightly
Intervention Type
Procedure
Intervention Name(s)
Soft tissue augmentation with CM
Intervention Description
Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation Placement of the Astra Tech dental implant (Dentsply, Germany) Modeling of sterile collagen matrix according to the shape of the recipient bed Fixation of the collagen matrix to the vestibular mucosal-periosteal flap Suturing the wound tightly
Primary Outcome Measure Information:
Title
The amount of soft tissue thickness gain
Description
The value of soft tissue thickness gain in the study area (mm) on the 90th day compared to the 0th day (initial value).To carry out the measurement an optical impression was taken using the Primescan intraoral scanner (Dentsply/SIRONA,Germany, 16.05.2019, № RD-27221/26851) before the operation and on the 90th day after the operation. Further, in the specialized program GOM Inspect the stl-files were compared and the vestibular contour changes were evaluated at 3 equidistant points in the coronary-apical direction. The мean value between the points was the amount of soft tissue thickness gain (mm).
Time Frame
[Day 90 compared to the 0th day (initial value)]
Secondary Outcome Measure Information:
Title
The amount of soft tissue thickness gain
Description
The value of soft tissue thickness gain in the study area (mm) on the 180th day compared to the 0th day (initial value).To carry out the measurement an optical impression was taken using the Primescan intraoral scanner (Dentsply/SIRONA,Germany, 16.05.2019, № RD-27221/26851) before the operation and on the 180th day after the operation. Further, in the specialized program GOM Inspect the stl-files were compared and the vestibular contour changes were evaluated at 3 equidistant points in the coronary-apical direction. The мean value between the points was the amount of soft tissue thickness gain (mm).
Time Frame
[Day 180 compared to the 0th day (initial value)]
Title
Assessment of the severity of pain syndrome
Description
Visual Analogue Scale (VAS). Evaluation of the severity of pain syndrome was carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain.
Time Frame
[Day 1 compared to the 0th day (initial value)].
Title
Assessment of the severity of pain syndrome
Description
Visual Analogue Scale (VAS). Evaluation of the severity of pain syndrome was carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain.
Time Frame
[Day 3 compared to the 0th day (initial value)].
Title
Assessment of the severity of pain syndrome
Description
Visual Analogue Scale (VAS). Evaluation of the severity of pain syndrome was carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain.
Time Frame
[Day 5 compared to the 0th day (initial value)].
Title
Assessment of the severity of pain syndrome
Description
Visual Analogue Scale (VAS). Evaluation of the severity of pain syndrome was carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain.
Time Frame
[Day 7 compared to the 0th day (initial value)]
Title
Assessment of the severity of pain syndrome
Description
Visual Analogue Scale (VAS). Evaluation of the severity of pain syndrome was carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain.
Time Frame
[Day 90 compared to the 0th day (initial value)].
Title
Assessment of the severity of pain syndrome
Description
Visual Analogue Scale (VAS). Evaluation of the severity of pain syndrome was carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 3-4 - moderate pain; 5-6 - moderate-severe pain; 7-8 - severe pain; 9-10 - unbearable pain.
Time Frame
[Day 180 compared to the 0th day (initial value)]
Title
Assessment of the collateral edema
Description
Edema was clinically assessed by its volume (scores 0-2; 0 points - no edema, 1 point - moderate edema, 2 points - intense edema compared to the condition of adjacent tissues).
Time Frame
[Day 1 compared to the 0th day (initial value)].
Title
Assessment of the collateral edema
Description
Edema was clinically assessed by its volume (scores 0-2; 0 points - no edema, 1 point - moderate edema, 2 points - intense edema compared to the condition of adjacent tissues).
Time Frame
[Day 3 compared to the 0th day (initial value)].
Title
Assessment of the collateral edema
Description
Edema was clinically assessed by its volume (scores 0-2; 0 points - no edema, 1 point - moderate edema, 2 points - intense edema compared to the condition of adjacent tissues).
Time Frame
[Day 5 compared to the 0th day (initial value).]
Title
Assessment of the collateral edema
Description
Edema was clinically assessed by its volume (scores 0-2; 0 points - no edema, 1 point - moderate edema, 2 points - intense edema compared to the condition of adjacent tissues).
Time Frame
[Day 7 compared to the 0th day (initial value).]
Title
Assessment of consumption of analgesics
Description
Patients' analgesic consumption was assessed by estimating the number of packs of Nimesulide (100 mg) taken.
Time Frame
[Day 1 compared to the 0th day (initial value).]
Title
Assessment of consumption of analgesics
Description
Patients' analgesic consumption was assessed by estimating the number of packs of Nimesulide (100 mg) taken.
Time Frame
[Day 3 compared to the 0th day (initial value).]
Title
Assessment of consumption of analgesics
Description
Patients' analgesic consumption was assessed by estimating the number of packs of Nimesulide (100 mg) taken.
Time Frame
[Day 5 compared to the 0th day (initial value).]
Title
Assessment of consumption of analgesics
Description
Patients' analgesic consumption was assessed by estimating the number of packs of Nimesulide (100 mg) taken.
Time Frame
[Day 7 compared to the 0th day (initial value).]
Title
Assessment of the quality of life
Description
The patient's quality of life was assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. The questionnaire consists of 14 questions that provide patient's self-reported measure of dysfunction, discomfort and disability arising from oral conditions. Each question is scored on a 5-point scale: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = fairly often; 4 = very often/every day. The OHIP-14 total score can range from 0 to 56. Higher OHIP-14 scores indicate worse quality of life and lower scores indicate better quality of life.
Time Frame
[Day 7 compared to the 0th day (initial value).]
Title
Assessment of the quality of life
Description
The patient's quality of life was assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. The questionnaire consists of 14 questions that provide patient's self-reported measure of dysfunction, discomfort and disability arising from oral conditions. Each question is scored on a 5-point scale: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = fairly often; 4 = very often/every day. The OHIP-14 total score can range from 0 to 56. Higher OHIP-14 scores indicate worse quality of life and lower scores indicate better quality of life.
Time Frame
[Day 90-93 compared to the 0th day (initial value).]
Title
Assessment of the quality of life
Description
The patient's quality of life was assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. The questionnaire consists of 14 questions that provide patient's self-reported measure of dysfunction, discomfort and disability arising from oral conditions. Each question is scored on a 5-point scale: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = fairly often; 4 = very often/every day. The OHIP-14 total score can range from 0 to 56. Higher OHIP-14 scores indicate worse quality of life and lower scores indicate better quality of life.
Time Frame
[Day 180-186 compared to the 0th day (initial value).]
Title
Attached mucosa measurement
Description
The width of the keratinised attached mucosa was measured using the UNC-15 periodontal probe. This was done by determining the mucosa-gingival junction line on the vestibular side. The distance from this line to the apex of the alveolar ridge was correspond to the width of the keratinised attached mucosa.
Time Frame
[Day 0 (initial value)]
Title
Attached mucosa measurement
Description
The width of the keratinised attached mucosa was measured using the UNC-15 periodontal probe. This was done by determining the mucosa-gingival junction line on the vestibular side. The distance from this line to the apex of the alveolar ridge was correspond to the width of the keratinised attached mucosa.
Time Frame
[Day 90-93 compared to the 0th day (initial value)].
Title
Attached mucosa measurement
Description
The width of the keratinised attached mucosa was measured using the UNC-15 periodontal probe. This was done by determining the mucosa-gingival junction line on the vestibular side. The distance from this line to the apex of the alveolar ridge was correspond to the width of the keratinised attached mucosa.
Time Frame
[Day 180-186 compared to the 0th day (initial value)].
Title
Soft tissue aesthetics
Description
Evaluation of soft tissue aesthetics was carried out by visual inspection taking into account the PES (pink aesthetic score). The evaluation was carried out according to a score of 0-1-2, where 0 was the lowest value and 2 was the highest, the maximum achievable PES value was 14.
Time Frame
[Day 180-186 compared to the 0th day (initial value) ]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The presence of written informed consent of the patient to participate in the study; Age from 25 to 59 years; The presence of an included defect in the distal part of the lower jaw with a sufficient volume of bone tissue; Soft tissue thickness <3 mm on the vestibular side; Adjacent teeth without periodontal pathology, the depth of probing should not exceed 3 mm along the entire dentoalveolar furrow; Satisfactory level of oral hygiene; Patients without concomitant pathology or with concomitant pathology in the compensation stage. Non-inclusion criteria: Age less than 25 and more than 59 years; Hard smokers (more than 10 cigarettes a day); The presence of concomitant pathology in the stage of decompensation; Patients with malignant tumors, as well as patients with a history of radiation and chemotherapy over the past 5 years; Taking medications that affect the healing of soft tissues (nonsteroidal anti-inflammatory drugs, steroid drugs); Pregnancy and breastfeeding; Patients with mental disorders. Exclusion Criteria: Patients with infections either periodontally or periapically, which developed after inclusion in the study; Pregnancy following entrance into the study; Patients having poor oral hygiene or not wanting to carry out oral hygiene measures; Patients who, for one reason or another, could not complete the entire protocol to the end.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Igor Ashurko, ass.prof.
Organizational Affiliation
I.M. Sechenov First Moscow State Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
I.M. Sechenov First Moscow State Medical University
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparative Analysis Using the Collagen Matrix and Autogenous Graft: Clinical Course, Aesthetic Results

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