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Patient Perception and Clinical Efficacy of a Collagen Matrix for the Treatment of Peri-implantitis

Primary Purpose

Peri-Implantitis

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Acellular collagen matrix
Autogenous free gingival graft
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-Implantitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Informed consent after the detailed information on the study.
  • Adults aged at least 18 years old.
  • Candidates for receiving augmentation of the peri-implant keratinized mucosa.
  • Presence of the implant diagnosed with peri-implantitis (radiographic bone loss > 2 mm, with a probing depth > 5 mm, bleeding and/or suppuration (Lang et al., 2011)).
  • Absent or insufficient keratinized peri-implant mucosa (<2 mm).

Exclusion Criteria:

  • General contraindications for the dental/surgical treatment;
  • Inflammatory or autoimmune disease of the oral cavity;
  • Implant with radiographic intraosseous defects more than 3 mm;
  • Smokers > 10 cig/day;
  • Allergy to collagen or analgesics/anti-inflammatory non-steroid drugs;
  • History of cancer in various parts of the body which required radiotherapy or chemotherapy during the last 5 years;
  • Radiotherapy of the head or neck in the last 5 years;
  • Actual medication with immunosuppressors, bisphosphonates or high doses of corticosteroids;
  • Pregnant or lactating women;
  • Women in fertile age, who do not use effective methods of contraception;
  • Participants of other studies of biomedical investigation during the last 24 weeks before initiation of the study.

Sites / Locations

  • Faculty of Dentistry, Univesity Complutense, MadridRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acellular collagen matrix

Autogenous free gingival graft

Arm Description

In a test group, partial thickness-flap will be elevation will be performed, in order to create the vascular recipient bed for the randomized graft. Implant surface will be treated with ultrasound device, glycine powder and implantoplasty in case of the exposure of the rough surface. Acellular collagen matrix will be adapted and suture to the vascular bed.

In a control group, partial thickness-flap will be elevation will be performed, in order to create the vascular recipient bed for the randomized graft. Implant surface will be treated with ultrasound device, glycine powder and implantoplasty in case of the exposure of the rough surface. Free gingival graft will be harvested from the zone of the posterior palate, and then adapted and sutured to the vascular bed.

Outcomes

Primary Outcome Measures

Change in width of keratinized peri-implant mucosa
Measured by periodontal probe (UNC-15), as mm of keratinized mucosa in the midbuccal portion of the implant of interest

Secondary Outcome Measures

Bleeding on probing
Measured as presence or absence (binary value) of bleeding 10 seconds after probing with the periodontal probe in 6 point around each implant
Probing depth
Measured by periodontal probe (UNC-15) in millimeters in 6 points around each implant, and defined as a distance from the mucosal margin to the bottom of the peri-implant pocket
Recession
Measured by periodontal probe (UNC-15) in millimeters in 6 points around each implant, and defined as a distance from the implant platform to the mucosal margin
General satisfaction by the treatment
Measured by a questionnaire, using the visual analogue scale, in values from 0 to 100
Duration of surgery
Measured by the electronic timer in minutes, starting from the moment of first incision and ending with a last suture
Vestibulum depth
Measured in mm by a periodontal probe, as a distance from the mucosal margin to the point of greatest concavity of the mucobuccal fold

Full Information

First Posted
May 9, 2018
Last Updated
May 27, 2018
Sponsor
Universidad Complutense de Madrid
Collaborators
PerioCentrum Research
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1. Study Identification

Unique Protocol Identification Number
NCT03551145
Brief Title
Patient Perception and Clinical Efficacy of a Collagen Matrix for the Treatment of Peri-implantitis
Official Title
Patient Perception and Clinical Efficacy of Geistlich Mucograft® vs. Autologous Connective Tissue Graft for the Treatment of Peri-implantitis: Multi-centre Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
March 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid
Collaborators
PerioCentrum Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a multi-centre, randomized clinical trial which evaluates the efficiency of the collagen xenograft (Muco-Graft®) in comparison to the autologous connective tissue graft for the augmentation of keratinized mucosa and gaining hygienic access to the implants diagnosed with peri-implantitis.
Detailed Description
Nowadays, there is not enough evidence that evaluates the patient's perception of utilizing the soft tissue substitutes in comparison to the autologous connective tissue graft for the augmentation of the keratinized mucosa and gain of hygienic access to the implants with infectious pathology and with minimum or absent keratinized mucosa. Therefore, the aim of the study is to evaluate the change of clinical parameters of peri-implant health and the patient perception of the procedure for augmentation of the keratinized tissues around dental implants with peri-implantitis. The hypothesis is that collagen matrix of porcine origin is associated with lower patient morbidity, in comparison with autologous connective-tissue graft, when used for the augmentation of the keratinized tissues around endosseous dental implants with infectious pathology and with minimum or absent KT mucosa. A sample 48 patients will be recruited basing upon the diagnosis of peri-implantitis and absent or insufficient peri- implant mucosa. 1 month after the non-surgical treatment, surgical procedure will be performed. Peri-implant clinical and radiographic parameters, as well as patient perception of the therapy provided, will be evaluated before and at various stages (up to 52 weeks) after the surgical intervention. Also, change of vestibulum depth will be analyzed, as well as the time spent for the procedure measured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Multi-centre randomized clinical trial (2 centres) with the duration of 102 weeks for the evaluation of efficiency on the new collagen xenograft (Muco-Graft®) in comparison to the autologous connective tissue graft for the augmentation of keratinized mucosa and gaining hygienic access to the implants diagnosed with peri-implantitis
Masking
InvestigatorOutcomes Assessor
Masking Description
The examiners will be blinded. Envelopes will be prepared by a research assistant not involved as clinician or examiner. The clinicians involved will have no access to the data collection sheets or the group allocation, whilst the examiners will have no access to the patients' treatment notes or group allocation. The examiners will be blinded with regards to the participant treatment assignments. The measures will include no access to the dental records as to which treatment has been assigned. The patients are not to reveal their treatment assignment to the examiners. Unblinding is expected when patients present with adverse outcomes during the course of the study, e.g., emphysema.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acellular collagen matrix
Arm Type
Experimental
Arm Description
In a test group, partial thickness-flap will be elevation will be performed, in order to create the vascular recipient bed for the randomized graft. Implant surface will be treated with ultrasound device, glycine powder and implantoplasty in case of the exposure of the rough surface. Acellular collagen matrix will be adapted and suture to the vascular bed.
Arm Title
Autogenous free gingival graft
Arm Type
Active Comparator
Arm Description
In a control group, partial thickness-flap will be elevation will be performed, in order to create the vascular recipient bed for the randomized graft. Implant surface will be treated with ultrasound device, glycine powder and implantoplasty in case of the exposure of the rough surface. Free gingival graft will be harvested from the zone of the posterior palate, and then adapted and sutured to the vascular bed.
Intervention Type
Other
Intervention Name(s)
Acellular collagen matrix
Intervention Description
3D collagen matrix consists of the collagen porcine type I and III
Intervention Type
Other
Intervention Name(s)
Autogenous free gingival graft
Intervention Description
Autogenous graft harvested from the posterior palate
Primary Outcome Measure Information:
Title
Change in width of keratinized peri-implant mucosa
Description
Measured by periodontal probe (UNC-15), as mm of keratinized mucosa in the midbuccal portion of the implant of interest
Time Frame
Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks
Secondary Outcome Measure Information:
Title
Bleeding on probing
Description
Measured as presence or absence (binary value) of bleeding 10 seconds after probing with the periodontal probe in 6 point around each implant
Time Frame
Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks
Title
Probing depth
Description
Measured by periodontal probe (UNC-15) in millimeters in 6 points around each implant, and defined as a distance from the mucosal margin to the bottom of the peri-implant pocket
Time Frame
Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks
Title
Recession
Description
Measured by periodontal probe (UNC-15) in millimeters in 6 points around each implant, and defined as a distance from the implant platform to the mucosal margin
Time Frame
Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks
Title
General satisfaction by the treatment
Description
Measured by a questionnaire, using the visual analogue scale, in values from 0 to 100
Time Frame
0, 1, 2, 4, 12, 26 and 52 weeks
Title
Duration of surgery
Description
Measured by the electronic timer in minutes, starting from the moment of first incision and ending with a last suture
Time Frame
after completion of surgical intervention
Title
Vestibulum depth
Description
Measured in mm by a periodontal probe, as a distance from the mucosal margin to the point of greatest concavity of the mucobuccal fold
Time Frame
Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Informed consent after the detailed information on the study. Adults aged at least 18 years old. Candidates for receiving augmentation of the peri-implant keratinized mucosa. Presence of the implant diagnosed with peri-implantitis (radiographic bone loss > 2 mm, with a probing depth > 5 mm, bleeding and/or suppuration (Lang et al., 2011)). Absent or insufficient keratinized peri-implant mucosa (<2 mm). Exclusion Criteria: General contraindications for the dental/surgical treatment; Inflammatory or autoimmune disease of the oral cavity; Implant with radiographic intraosseous defects more than 3 mm; Smokers > 10 cig/day; Allergy to collagen or analgesics/anti-inflammatory non-steroid drugs; History of cancer in various parts of the body which required radiotherapy or chemotherapy during the last 5 years; Radiotherapy of the head or neck in the last 5 years; Actual medication with immunosuppressors, bisphosphonates or high doses of corticosteroids; Pregnant or lactating women; Women in fertile age, who do not use effective methods of contraception; Participants of other studies of biomedical investigation during the last 24 weeks before initiation of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Myroslav Solonko, DDS
Phone
34684354549
Email
msolonko@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alberto Ortiz-Vigón, PhD
Phone
‭34 629 755 893‬
Email
alberto@ortizvigon.com
Facility Information:
Facility Name
Faculty of Dentistry, Univesity Complutense, Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Figuero, Doctor
Phone
00913942018
Email
elfiguer@ucm.es
First Name & Middle Initial & Last Name & Degree
Mariano Sanz
First Name & Middle Initial & Last Name & Degree
Myroslav Solonko
First Name & Middle Initial & Last Name & Degree
Alberto Ortiz-Vigón

12. IPD Sharing Statement

Learn more about this trial

Patient Perception and Clinical Efficacy of a Collagen Matrix for the Treatment of Peri-implantitis

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