Peri-Implantitis
Conditions
Brief 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.
Detailed 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.
Interventions
PROCEDUREMembrane 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.
Sponsors
University of Michigan
Osteogenics Biomedical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probing depth measurements in millimeters | About 5 weeks before baseline surgery and at 8.5 months after baseline surgery. | To compare probing depth measurements using a periodontal probe after peri-implantitis treatment |
| Bone measurements in millimeters | Baseline and 8 months after baseline surgery | Bone measurements obtained from CBCT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical attachment levels in millimeters | 8 months after baseline surgery | To compare clinical attachment measurements using a periodontal probe from baseline to the final follow-up visit |
| Marginal bone levels in millimeters at the implant site | 8 months after baseline surgery | To compare marginal bone measurements from periapical radiographs |
| Volumetric changes of grafted area in cubic millimeters | 8 months after baseline surgery | To compare volumetric bone measurements of the grafted areas from CBCT |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMuhammad Saleh, BDS, MSD
University of Michigan
Outcome results
None listed