Clinical trial NCT03551145: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Peri-Implantitis
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: PerioCentrum Research
First posted: 2018-06-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in width of keratinized peri-implant mucosa
timeFrame: Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks
Secondary outcomes:
measure: Bleeding on probing
timeFrame: Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks
measure: Probing depth
timeFrame: Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks
measure: Recession
timeFrame: Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks
measure: General satisfaction by the treatment
timeFrame: 0, 1, 2, 4, 12, 26 and 52 weeks
measure: Duration of surgery
timeFrame: after completion of surgical intervention
measure: Vestibulum depth
timeFrame: Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Faculty of Dentistry, Univesity Complutense, Madrid
Study officials:
References: