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

NCT03551145 | Unknown Phase 4

• 1 other identifier: 16/502-P
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks

Secondary Outcomes (6)

• Bleeding on probing

  Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks

• Probing depth

  Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks

• Recession

  Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks

• General satisfaction by the treatment

  0, 1, 2, 4, 12, 26 and 52 weeks

• Duration of surgery

  after completion of surgical intervention

Study Arms (2)

Acellular collagen matrix

EXPERIMENTAL

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.

Other: Acellular collagen matrix

Autogenous free gingival graft

ACTIVE COMPARATOR

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.

Other: Autogenous free gingival graft

Interventions

Acellular collagen matrix OTHER

3D collagen matrix consists of the collagen porcine type I and III

Acellular collagen matrix

Autogenous free gingival graft OTHER

Autogenous graft harvested from the posterior palate

Autogenous free gingival graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• PerioCentrum Research: collaborator

Study Sites (1)

Faculty of Dentistry, Univesity Complutense, Madrid

Madrid, 28040, Spain

RECRUITING

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Myroslav Solonko, DDS

CONTACT

34684354549; msolonko@gmail.com

Alberto Ortiz-Vigón, PhD

CONTACT

‭34 629 755 893‬; alberto@ortizvigon.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: June 11, 2018
• Study Start: February 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: March 1, 2020
• Last Updated: June 11, 2018

Record last verified: 2018-05

Locations

ES (1)