Using a dermal matrix to improve treatment for peri-implantitis
Adjunctive Use of Dermal Matrix to Compensate Dimensional Changes in the Reconstructive Therapy of Peri-implantitis: Multi-Center Randomized Controlled Trial
NA · Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain · NCT06398288
This study is testing if using a special skin-like material can help people with dental implant issues heal better and look nicer when combined with a new cleaning method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain (other) |
| Locations | 1 site (Badajoz) |
| Trial ID | NCT06398288 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of a dermal matrix in conjunction with an electrolytic approach to treat peri-implantitis, a condition affecting dental implants. The electrolytic method involves applying a negative voltage to the implant while using a sodium formiate solution to detoxify the implant surface. Participants will be divided into two groups: one receiving the dermal matrix and the other not. The goal is to assess whether the dermal matrix can enhance healing and aesthetic outcomes in patients with peri-implantitis-related bone defects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with diagnosed peri-implantitis and specific bone defects who are non-smokers and have no systemic diseases affecting bone metabolism.
Not a fit: Patients with uncontrolled medical conditions, active periodontal disease, or those who smoke may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved healing and aesthetic results for patients suffering from peri-implantitis.
How similar studies have performed: While the electrolytic approach is relatively novel, similar studies have shown promise in improving outcomes for peri-implantitis treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Diagnosed with peri-implantitis-related intrabony defects * All subjects had dental implants with screw-retained or cement-retained fixed or removable implant-supported prosthesis for a minimum of 36 months. * All patients in age of 18 to 80, non-smokers * With no presence of systemic disease or medication known to alter bone metabolism, and partial or complete edentulous patients that have no active periodontal disease. Exclusion criteria: * Peri-implantitis-related supra-crystal or combined defects * Pregnancy or lactation * History of or current smokers * Uncontrolled medical conditions, * Cement-retained restorations, * Lacking keratinized mucosa (≤2mm) on the lingual or buccal implant sites.
Where this trial is running
Badajoz
- Centro de Implantologia Cirugia Oral y Maxiofacial — Badajoz, Spain (RECRUITING)
Study contacts
- Principal investigator: Alberto Monje, DDS — Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
- Study coordinator: Mamen Tomé, DH
- Email: mtome@periocicom.com
- Phone: 924203045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peri-Implantitis