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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2020-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peri-Implantitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

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Acellular collagen matrix

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.

Group Type EXPERIMENTAL

Acellular collagen matrix

Intervention Type OTHER

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

Autogenous free gingival graft

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.

Group Type ACTIVE_COMPARATOR

Autogenous free gingival graft

Intervention Type OTHER

Autogenous graft harvested from the posterior palate

Interventions

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Acellular collagen matrix

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

Intervention Type OTHER

Autogenous free gingival graft

Autogenous graft harvested from the posterior palate

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes