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

Universidad Complutense de Madrid

Status and phase: Unknown; Phase 4

Conditions: Peri-Implantitis

Treatments: Other: Acellular collagen matrix; Other: Autogenous free gingival graft

Study type: Interventional

Funder types: Other

Identifiers

NCT03551145

16/502-P

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Acellular collagen matrix

Experimental group

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.

Treatment:

Other: Acellular collagen matrix

Autogenous free gingival graft

Active Comparator group

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.

Treatment:

Other: Autogenous free gingival graft