Peri-Implantitis
Conditions
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.
Interventions
OTHERAcellular collagen matrix
3D collagen matrix consists of the collagen porcine type I and III
OTHERAutogenous free gingival graft
Autogenous graft harvested from the posterior palate
Sponsors
PerioCentrum Research
Universidad Complutense de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes 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.
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in width of keratinized peri-implant mucosa | Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks | Measured by periodontal probe (UNC-15), as mm of keratinized mucosa in the midbuccal portion of the implant of interest |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probing depth | Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks | 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 | Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks | 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 |
| Bleeding on probing | Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks | Measured as presence or absence (binary value) of bleeding 10 seconds after probing with the periodontal probe in 6 point around each implant |
| Duration of surgery | after completion of surgical intervention | Measured by the electronic timer in minutes, starting from the moment of first incision and ending with a last suture |
| Vestibulum depth | Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks | Measured in mm by a periodontal probe, as a distance from the mucosal margin to the point of greatest concavity of the mucobuccal fold |
| General satisfaction by the treatment | 0, 1, 2, 4, 12, 26 and 52 weeks | Measured by a questionnaire, using the visual analogue scale, in values from 0 to 100 |
Countries
Spain
Contacts
Primary ContactMyroslav Solonko, DDS
Backup ContactAlberto Ortiz-Vigón, PhD
Outcome results
None listed