Effect of Concave Healing Abutment on Gum Healing
Effect of the Shape of the Healing Abutment on Soft Tissue Healing. A Randomized Clinical Study Involving an Enhanced Digital Superposition Methodology
This study is testing if a special type of dental implant abutment helps gums heal better than the standard type for people getting implants in the back of their mouths.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | MIS Implant Technologies, Ltd Industry-sponsored |
| Drugs / interventions | Denosumab, chemotherapy, radiation |
| Locations | 1 site (Misgav) |
| Trial ID | NCT05975814 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the impact of concave healing abutments on soft tissue healing compared to traditional straight abutments in dental implant therapy. Participants will undergo a series of clinical and radiographic assessments, including 3D cone-beam computed tomography and intra-oral scans, to establish baseline soft tissue outlines. Implants will be placed using a standardized surgical protocol, and the type of abutment used will be determined through randomization. The study will focus on patients requiring implants in the posterior areas of the mandible and maxilla.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old in good health who require dental implants in the posterior mandible or maxilla.
Not a fit: Patients with uncontrolled medical conditions or those who have undergone recent chemotherapy or radiation treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance soft tissue healing around dental implants, leading to improved aesthetic and functional outcomes for patients.
How similar studies have performed: While similar studies have explored various abutment designs, the specific focus on concave healing abutments in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: a) patients older than 18 years in need of implant therapy in the posterior area of the mandible and maxilla, b) good general/systemic health (ASA type I, II), c) patients who committed to attend all visits of the study, d) placement of a Ø 4.2 mm implant without requiring bone augmentation, e) adequate oral hygiene with FMPS (full mouth plaque score) \< 15% before surgery, f) absence of uncontrolled periodontal disease, g) agreeing to sign an informed consent. Exclusion Criteria: a) patients with a contributing medical history in which any surgery, disease, condition, or medication susceptible to compromise the healing of soft and hard tissues (e.g. non-controlled diabetes), b) liver function disorder, c) immune system disease, d) immunosuppressant drugs, e) toxic habits other than smoking that might compromise or affect healing, f) patients who have undergone chemotherapy or radiation treatment during the previous 5 years comprising the head and neck area, g) corticosteroids therapy or any other medication that could influence postoperative healing and/or osseointegration, h) bisphosphonate or Denosumab therapy (Prolia®), i) sites that underwent or require a horizontal or vertical bone regeneration procedure, j) inability or unwillingness to attend follow-up visits, k) patients unwilling to sign an informed consent form.
Where this trial is running
Misgav
- Mis Implants Technologies Ltd. — Misgav, Israel (Recruiting)
Study contacts
- Principal investigator: Rasmus Sperber, Dr — Sachen Praxen
- Study coordinator: Thilo Damaskos, Dr
- Email: thilo.damaskos@gmx.de
- Phone: +41 170 228 2816
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.