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Clinical and Histological Outcomes of Using Collagen Matrix or Soft Tissue Graft Around Implants

Primary Purpose

Soft Tissue Atrophy

Status
Active
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Soft tissue augmentation
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

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The presence of written informed consent of the patient to participate in the study;
  2. The presence of an included defect (1 teeth) in the distal part of the lower jaw with a sufficient volume of bone tissue;
  3. Deficiency of soft tissue thickness;
  4. Adjacent teeth are without any of periodontal disease, namely the absence of periodontal probing depth > 3 mm in any site of adjacent teeth;

6. Satisfactory level of oral hygiene, namely full mouth plaque score < 20% and full mouth bleeding score < 20%;

Non-inclusion criteria:

  1. The presence of concomitant pathology in the stage of decompensation;
  2. Hard smokers (more than 10 cigarettes per day);
  3. Radio and chemotherapy in history over the past 5 years;
  4. Pregnancy and breastfeeding;
  5. Taking medications that affect the healing of soft tissues (nonsteroidal anti-inflammatory drug, steroid drugs).

Exclusion Criteria:

  1. Patients with infections either periodontally or periapically;
  2. Pregnantcy following entrance into the study;
  3. Patients having poor oral hygiene or not wanting to carry out oral hygiene measures;
  4. Subjects, who in the opinion of the investigator, for any reason will not be able to complete the study per protocol.

Sites / Locations

  • I.M. Sechenov First Moscow State Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

1 group

2 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 tuber region on the upper jaw.

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

Outcomes

Primary Outcome Measures

The amount of soft tissue thickness gain
To carry out the measurement an optical impression will be taken using the Primescan intraoral scanner (Dentsply/SIRONA) before the operation and on the 90th day after the operation. Further, in the specialized program GOM Inspect the stl-files will be compared and the vestibular contour changes will be evaluated at 3 equidistant points in the coronary-apical direction.

Secondary Outcome Measures

VAS scale
Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 2-3 - moderate pain; 4-5 - moderate-severe pain; 6-7 - severe pain; 8-10 - unbearable pain.
VAS scale
Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 2-3 - moderate pain; 4-5 - moderate-severe pain; 6-7 - severe pain; 8-10 - unbearable pain.
VAS scale
Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 2-3 - moderate pain; 4-5 - moderate-severe pain; 6-7 - severe pain; 8-10 - unbearable pain.
VAS scale
Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 2-3 - moderate pain; 4-5 - moderate-severe pain; 6-7 - severe pain; 8-10 - unbearable pain.
VAS scale
Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 2-3 - moderate pain; 4-5 - moderate-severe pain; 6-7 - severe pain; 8-10 - unbearable pain.
VAS scale
Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 2-3 - moderate pain; 4-5 - moderate-severe pain; 6-7 - severe pain; 8-10 - unbearable pain.
OHIP-14 questionnaire
Description: Evaluation of the patients' quality of life is carried out using a questionnaire. Depending on the severity of the trait it is necessary to answer the following questions from 0 to 4 points: Have you had trouble pronouncing any words because of problems with your teeth or mouth? Have you felt that your sense of taste has worsened because of problems with your teeth or mouth? Have you had painful aching in your mouth? Have you found it uncomfortable to eat any foods because of problems with your teeth or mouth? Have you been self-conscious because of your teeth or mouth? Have you felt tense because of problems with your teeth or mouth? Has been your diet been unsatisfactory because of problems with your teeth of mouth? Have you had to interrupt meals because of problems with your teeth or mouth? Have you found it difficult to relax because of problems with your teeth or mouth? Have you been a bit embarrassed because of problems with your teeth or mouth? Have you been a bit
OHIP-14 questionnaire
Description: Evaluation of the patients' quality of life is carried out using a questionnaire. Depending on the severity of the trait it is necessary to answer the following questions from 0 to 4 points: Have you had trouble pronouncing any words because of problems with your teeth or mouth? Have you felt that your sense of taste has worsened because of problems with your teeth or mouth? Have you had painful aching in your mouth? Have you found it uncomfortable to eat any foods because of problems with your teeth or mouth? Have you been self-conscious because of your teeth or mouth? Have you felt tense because of problems with your teeth or mouth? Has been your diet been unsatisfactory because of problems with your teeth of mouth? Have you had to interrupt meals because of problems with your teeth or mouth? Have you found it difficult to relax because of problems with your teeth or mouth? Have you been a bit embarrassed because of problems with your teeth or mouth? Have you been a bit
OHIP-14 questionnaire
Description: Evaluation of the patients' quality of life is carried out using a questionnaire. Depending on the severity of the trait it is necessary to answer the following questions from 0 to 4 points: Have you had trouble pronouncing any words because of problems with your teeth or mouth? Have you felt that your sense of taste has worsened because of problems with your teeth or mouth? Have you had painful aching in your mouth? Have you found it uncomfortable to eat any foods because of problems with your teeth or mouth? Have you been self-conscious because of your teeth or mouth? Have you felt tense because of problems with your teeth or mouth? Has been your diet been unsatisfactory because of problems with your teeth of mouth? Have you had to interrupt meals because of problems with your teeth or mouth? Have you found it difficult to relax because of problems with your teeth or mouth? Have you been a bit embarrassed because of problems with your teeth or mouth? Have you been a bit
OHIP-14 questionnaire
Description: Evaluation of the patients' quality of life is carried out using a questionnaire. Depending on the severity of the trait it is necessary to answer the following questions from 0 to 4 points: Have you had trouble pronouncing any words because of problems with your teeth or mouth? Have you felt that your sense of taste has worsened because of problems with your teeth or mouth? Have you had painful aching in your mouth? Have you found it uncomfortable to eat any foods because of problems with your teeth or mouth? Have you been self-conscious because of your teeth or mouth? Have you felt tense because of problems with your teeth or mouth? Has been your diet been unsatisfactory because of problems with your teeth of mouth? Have you had to interrupt meals because of problems with your teeth or mouth? Have you found it difficult to relax because of problems with your teeth or mouth? Have you been a bit embarrassed because of problems with your teeth or mouth? Have you been a bit
Attached mucosa measurement
The width of the keratinised attached mucosa is measured using the UNC-15 periodontal probe. This is done by determining the mucosa-gingival junction line on the vestibular side. The distance from this line to the apex of the alveolar ridge will correspond to the width of the keratinised attached mucosa.
Attached mucosa measurement
The width of the keratinised attached mucosa is measured using the UNC-15 periodontal probe. This is done by determining the mucosa-gingival junction line on the vestibular side. The distance from this line to the apex of the alveolar ridge will correspond to the width of the keratinised attached mucosa.

Full Information

First Posted
November 5, 2021
Last Updated
November 5, 2021
Sponsor
I.M. Sechenov First Moscow State Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05123898
Brief Title
Clinical and Histological Outcomes of Using Collagen Matrix or Soft Tissue Graft Around Implants
Official Title
Comparative Analysis of the Effectiveness of Free Connective Tissue Graft and Xenogenic Collagen Matrix Transplantation in Patients With Dental Implants.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 14, 2020 (Actual)
Primary Completion Date
July 28, 2021 (Actual)
Study Completion Date
November 20, 2021 (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
Yes

5. Study Description

Brief Summary
This was an interventional prospective randomized clinical trial (RCT) in parallel groups. The sample size is 35 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 "Fibromatrix" (LLC "Cardioplant", Russia; registration in Russia 20/05/2019 No FSZ 2019/83671). In the postoperative period the value of soft tissue thickness gain, duration of surgery, severity of pain syndrome and quality of life were assessed. Also, after 3 months simultaneously with installation of gingiva formers biopsy specimens were sampled with mucotome in the area of the intervention followed by histomorphometric analysis of the obtained biopsies.
Detailed Description
The aim of this research was to perform a comparative clinical and histomorphometric analysis of soft tissues in the area of soft tissue graft and collagen matrix transplantation. Thirty five patients diagnosed with partial absence of teeth were 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 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=15) transplantation of a free connective tissue graft (CTG) from tuberosity area of the upper jaw was performed. In 2 group (n=20) collagen matrix "Fibromatrix" 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 Ostem (Osstem Implant Co., Ltd., Korea; registration in Russia 05.09.2018 No FSZ 2018/7577). 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 "Fibromatrix" was fixed to the buccal muco-periosteal flap (LLC "Cardioplant", Russia; registration in Russia 20.05.2019 No № FSZ 2019/83671). For patients of all groups mobilization of the muco-periosteal flap conducted followed by suturing the wound tightly without tension with simple interrupted sutures. In the early postoperative period the standard antibacterial and anti-inflammatory therapy in combination with the use of local antiseptics for daily care was prescribed. The stage of the implant uncovering with hilling abutments installation was carried out 3 months after the intervention. At this stage, a soft tissue fragment was taken using a mucotome in the area of the previously performed mucous membrane thickness increasing for subsequent histomorphometric analysis. In the study we used both conventional light microscopy (microscopy in the light field) and polarizing microscopy - to estimate the content of collagen fibers in preparations stained with picrosirius red. During a morphometric study we carried out a quantitative assessment of the characteristics of the epithelial layer, the basement membrane relative length (the ratio of the absolute length of the basement membrane to the length of the epithelial layer), the characteristics of the underlying connective tissue.

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
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 group
Arm Type
Other
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 tuber region on the upper jaw.
Arm Title
2 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 "Fibromatrix"
Intervention Type
Procedure
Intervention Name(s)
Soft tissue augmentation
Intervention Description
Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation Placement of the Ostem dental implant (Osstem Implant Co., Ltd.) Modeling of sterile collagen matrix according to the shape of the recipient bed Fixation of the collagen matrix to the vestibular flap Suturing the wound tightly
Primary Outcome Measure Information:
Title
The amount of soft tissue thickness gain
Description
To carry out the measurement an optical impression will be taken using the Primescan intraoral scanner (Dentsply/SIRONA) before the operation and on the 90th day after the operation. Further, in the specialized program GOM Inspect the stl-files will be compared and the vestibular contour changes will be evaluated at 3 equidistant points in the coronary-apical direction.
Time Frame
Days 90
Secondary Outcome Measure Information:
Title
VAS scale
Description
Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 2-3 - moderate pain; 4-5 - moderate-severe pain; 6-7 - severe pain; 8-10 - unbearable pain.
Time Frame
1 day
Title
VAS scale
Description
Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 2-3 - moderate pain; 4-5 - moderate-severe pain; 6-7 - severe pain; 8-10 - unbearable pain.
Time Frame
3 days
Title
VAS scale
Description
Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 2-3 - moderate pain; 4-5 - moderate-severe pain; 6-7 - severe pain; 8-10 - unbearable pain.
Time Frame
5 days
Title
VAS scale
Description
Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 2-3 - moderate pain; 4-5 - moderate-severe pain; 6-7 - severe pain; 8-10 - unbearable pain.
Time Frame
7 days
Title
VAS scale
Description
Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 2-3 - moderate pain; 4-5 - moderate-severe pain; 6-7 - severe pain; 8-10 - unbearable pain.
Time Frame
30 days
Title
VAS scale
Description
Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where : 0 - absence of pain; 1-2 - weak pain; 2-3 - moderate pain; 4-5 - moderate-severe pain; 6-7 - severe pain; 8-10 - unbearable pain.
Time Frame
90 days
Title
OHIP-14 questionnaire
Description
Description: Evaluation of the patients' quality of life is carried out using a questionnaire. Depending on the severity of the trait it is necessary to answer the following questions from 0 to 4 points: Have you had trouble pronouncing any words because of problems with your teeth or mouth? Have you felt that your sense of taste has worsened because of problems with your teeth or mouth? Have you had painful aching in your mouth? Have you found it uncomfortable to eat any foods because of problems with your teeth or mouth? Have you been self-conscious because of your teeth or mouth? Have you felt tense because of problems with your teeth or mouth? Has been your diet been unsatisfactory because of problems with your teeth of mouth? Have you had to interrupt meals because of problems with your teeth or mouth? Have you found it difficult to relax because of problems with your teeth or mouth? Have you been a bit embarrassed because of problems with your teeth or mouth? Have you been a bit
Time Frame
0 day
Title
OHIP-14 questionnaire
Description
Description: Evaluation of the patients' quality of life is carried out using a questionnaire. Depending on the severity of the trait it is necessary to answer the following questions from 0 to 4 points: Have you had trouble pronouncing any words because of problems with your teeth or mouth? Have you felt that your sense of taste has worsened because of problems with your teeth or mouth? Have you had painful aching in your mouth? Have you found it uncomfortable to eat any foods because of problems with your teeth or mouth? Have you been self-conscious because of your teeth or mouth? Have you felt tense because of problems with your teeth or mouth? Has been your diet been unsatisfactory because of problems with your teeth of mouth? Have you had to interrupt meals because of problems with your teeth or mouth? Have you found it difficult to relax because of problems with your teeth or mouth? Have you been a bit embarrassed because of problems with your teeth or mouth? Have you been a bit
Time Frame
7 days
Title
OHIP-14 questionnaire
Description
Description: Evaluation of the patients' quality of life is carried out using a questionnaire. Depending on the severity of the trait it is necessary to answer the following questions from 0 to 4 points: Have you had trouble pronouncing any words because of problems with your teeth or mouth? Have you felt that your sense of taste has worsened because of problems with your teeth or mouth? Have you had painful aching in your mouth? Have you found it uncomfortable to eat any foods because of problems with your teeth or mouth? Have you been self-conscious because of your teeth or mouth? Have you felt tense because of problems with your teeth or mouth? Has been your diet been unsatisfactory because of problems with your teeth of mouth? Have you had to interrupt meals because of problems with your teeth or mouth? Have you found it difficult to relax because of problems with your teeth or mouth? Have you been a bit embarrassed because of problems with your teeth or mouth? Have you been a bit
Time Frame
30 days
Title
OHIP-14 questionnaire
Description
Description: Evaluation of the patients' quality of life is carried out using a questionnaire. Depending on the severity of the trait it is necessary to answer the following questions from 0 to 4 points: Have you had trouble pronouncing any words because of problems with your teeth or mouth? Have you felt that your sense of taste has worsened because of problems with your teeth or mouth? Have you had painful aching in your mouth? Have you found it uncomfortable to eat any foods because of problems with your teeth or mouth? Have you been self-conscious because of your teeth or mouth? Have you felt tense because of problems with your teeth or mouth? Has been your diet been unsatisfactory because of problems with your teeth of mouth? Have you had to interrupt meals because of problems with your teeth or mouth? Have you found it difficult to relax because of problems with your teeth or mouth? Have you been a bit embarrassed because of problems with your teeth or mouth? Have you been a bit
Time Frame
90 days
Title
Attached mucosa measurement
Description
The width of the keratinised attached mucosa is measured using the UNC-15 periodontal probe. This is done by determining the mucosa-gingival junction line on the vestibular side. The distance from this line to the apex of the alveolar ridge will correspond to the width of the keratinised attached mucosa.
Time Frame
0 day
Title
Attached mucosa measurement
Description
The width of the keratinised attached mucosa is measured using the UNC-15 periodontal probe. This is done by determining the mucosa-gingival junction line on the vestibular side. The distance from this line to the apex of the alveolar ridge will correspond to the width of the keratinised attached mucosa.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The presence of written informed consent of the patient to participate in the study; The presence of an included defect (1 teeth) in the distal part of the lower jaw with a sufficient volume of bone tissue; Deficiency of soft tissue thickness; Adjacent teeth are without any of periodontal disease, namely the absence of periodontal probing depth > 3 mm in any site of adjacent teeth; 6. Satisfactory level of oral hygiene, namely full mouth plaque score < 20% and full mouth bleeding score < 20%; Non-inclusion criteria: The presence of concomitant pathology in the stage of decompensation; Hard smokers (more than 10 cigarettes per day); Radio and chemotherapy in history over the past 5 years; Pregnancy and breastfeeding; Taking medications that affect the healing of soft tissues (nonsteroidal anti-inflammatory drug, steroid drugs). Exclusion Criteria: Patients with infections either periodontally or periapically; Pregnantcy following entrance into the study; Patients having poor oral hygiene or not wanting to carry out oral hygiene measures; Subjects, who in the opinion of the investigator, for any reason will not be able to complete the study per protocol.
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
IPD Sharing Plan Description
IPD Sharing is impossible because of the recommendation of the local ethics committee

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Clinical and Histological Outcomes of Using Collagen Matrix or Soft Tissue Graft Around Implants

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