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

Peri-Implantitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03551145
• Other study ID #: 16/502-P
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2017
• Est. completion date: March 1, 2020

Study information

• Verified date: May 2018
• Source: Universidad Complutense de Madrid
• Contact: Myroslav Solonko, DDS
• Phone: 34684354549
• Email: msolonko[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

Other:
• Acellular collagen matrix
3D collagen matrix consists of the collagen porcine type I and III
• Autogenous free gingival graft
Autogenous graft harvested from the posterior palate

Locations

Country	Name	City	State
Spain	Faculty of Dentistry, Univesity Complutense, Madrid	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	PerioCentrum Research

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Bleeding on probing	Measured as presence or absence (binary value) of bleeding 10 seconds after probing with the periodontal probe in 6 point around each implant	Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks
Secondary	Probing depth	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	Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks
Secondary	Recession	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	Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks
Secondary	General satisfaction by the treatment	Measured by a questionnaire, using the visual analogue scale, in values from 0 to 100	0, 1, 2, 4, 12, 26 and 52 weeks
Secondary	Duration of surgery	Measured by the electronic timer in minutes, starting from the moment of first incision and ending with a last suture	after completion of surgical intervention
Secondary	Vestibulum depth	Measured in mm by a periodontal probe, as a distance from the mucosal margin to the point of greatest concavity of the mucobuccal fold	Baseline, 0, 1, 2, 4, 12, 26 and 52 weeks