Regenerative Treatment of Peri-implantitis

Peri-Implantitis Clinical Trial

Official title:

Regenerative Treatment of Peri-implantitis: A Comparison of the Reinforced PTFE Mesh (RPM) and the Collagen Membrane in the Submerged Approach: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06153212
• Other study ID #: HUM00169735
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 2, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: December 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to study the use of a new type of d-PTFE membrane called reinforced PTFE Mesh (RPM) with dental surgery. The regenerative outcomes of RPM membranes and collagen membrane for surgical reconstructive treatment of peri-implantitis (gum disease around implants) will be compared.

Description:

Peri-implantitis is an inflammatory response that leads to irreversible loss of implant supporting bone. This study will investigate the regenerative outcomes obtained with two membranes for surgical reconstructive treatment of peri-implantitis defects when the implant is submerged and primary wound closure is obtained. In one group the newly designed d-PTFE membrane with macropores, known as the RPM membrane will be utilized, which will be compared to the traditional collagen membrane used in the other group. The clinical, radiographic, and histologic outcomes for the regenerative treatment of peri-implantitis when utilizing the same bone graft in combination with either a collagen membrane or the RPM will be evaluated via a parallel-arm randomized controlled clinical trial.

32 patients with peri-implantitis will be recruited and randomized to receive peri-implantitis treatment with either a collagen membrane or an RPM membrane.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 32
• Est. completion date: December 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Physical status according to the American Society of Anesthesiology (ASA) I or II, which include patients who are systematically healthy or may suffer from mild to moderate, however well-controlled systemic diseases.

• Subjects having at least one dental implant with peri-implantitis according to the definition proposed by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Berglundh et al., 2018):

• Full-mouth plaque score and full-mouth bleeding score = 20% (measured at four sites per tooth)

• Correct 3-dimensional implant positioning, or buccal position = 1 mm

• Implants which have been in function for at least 6 months

Exclusion Criteria:

• A clearly mal-positioned dental implant

• Significant interproximal horizontal bone loss (more than 50% of implant fixture length)

• A mobile dental implant

• Presence of uncontrolled or untreated periodontal disease

• More than 2 weeks usage of antibiotics in the past two months

• Subjects taking medications known to modify bone metabolism or those that can interfere with the normal wound healing (such as bisphosphonates, corticosteroids, hormone replacement therapy, parathyroid hormone, denosumab, strontium ranelate, etc.), or those with uncontrolled systemic diseases or conditions that may similarly affect the patient's healing (osteoporosis, osteopenia, hyperparathyroidism, Paget's disease, uncontrolled diabetes (HBA1c > 8)).

• Pregnant subjects or individuals attempting to get pregnant (self-reported)

• Subjects smoking more than 10 cigarettes a day, or those with a history of drug or alcohol abuse (self-reported)

• Subjects unable to maintain adequate oral hygiene (O'Leary plaque index more than 50%) (O'Leary et al., 1972)

• Any other contraindications for undergoing periodontal surgery

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

Procedure:
• Membrane placement with bone grafting
The diseased dental implant will be cleaned and the bone defect will be filled with bone graft and covered by a membrane.

Locations

Country	Name	City	State
United States	University of Michigan School of Dentistry	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Osteogenics Biomedical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing depth measurements in millimeters	To compare probing depth measurements using a periodontal probe after peri-implantitis treatment	About 5 weeks before baseline surgery and at 8.5 months after baseline surgery.
Primary	Bone measurements in millimeters	Bone measurements obtained from CBCT	Baseline and 8 months after baseline surgery
Secondary	Clinical attachment levels in millimeters	To compare clinical attachment measurements using a periodontal probe from baseline to the final follow-up visit	8 months after baseline surgery
Secondary	Marginal bone levels in millimeters at the implant site	To compare marginal bone measurements from periapical radiographs	8 months after baseline surgery
Secondary	Volumetric changes of grafted area in cubic millimeters	To compare volumetric bone measurements of the grafted areas from CBCT	8 months after baseline surgery