Comparing two methods for improving gum tissue around dental implants
Strip Graft With Xenogeneic Matrix Versus Free Gingival Graft for the Augmentation of Peri-implant Keratinized Mucosa: A Randomized Clinical Trial With Vascular Analysis
NA · Universidad Complutense de Madrid · NCT06261268
This study is testing two different surgical methods to see which one better improves gum tissue around dental implants for patients who need extra support.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Universidad Complutense de Madrid (other) |
| Locations | 1 site (Madrid) |
| Trial ID | NCT06261268 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a strip graft combined with a xenogeneic matrix versus a free gingival graft for augmenting peri-implant keratinized mucosa in patients with inadequate tissue around dental implants. The primary focus is on changes in the thickness and quality of the gum tissue following these two surgical approaches. Additionally, the study will assess postoperative blood supply and microcirculation at both the donor and recipient sites, along with patient-reported outcomes and aesthetic results. By comparing these methods, the study seeks to identify a less invasive and more aesthetically pleasing option for patients requiring gum tissue augmentation.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults over 18 years with short-span dental implants in the mandible and less than 2 mm of peri-implant keratinized mucosa.
Not a fit: Patients with compromised health status, significant smoking habits, or a history of previous mucogingival surgeries in the area of interest may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a less invasive option for improving gum tissue around dental implants, leading to better aesthetic outcomes and reduced surgical discomfort.
How similar studies have performed: While the use of xenogeneic matrices has shown promising outcomes in previous studies, this specific combination approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients older than 18 years * Short-span dental implants in the mandible at second stage with inadequate PIKM (\<2 mm) with at least one adjacent tooth mesially * Periodontally healthy patients with a pristine or reduced periodontium * Plaque index (FMPS) less than 20%. Exclusion Criteria: * Compromised general health status that contraindicates study procedures (≥ASA III); * Drug or alcohol abuse; * Smoking of \> 10 cigarettes per day; * Chronic use of corticosteroids, NSAIDs or immunomodulators (any type or dose); * Pregnant or lactating women; * History of previous mucogingival surgeries in the area of interest
Where this trial is running
Madrid
- Complutense University — Madrid, Spain (RECRUITING)
Study contacts
- Study coordinator: Mariano Sanz Alonso, DMD
- Email: marsan@ucm.es
- Phone: 913942021
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-Implantational Loss, Surgical Wound, Healing Surgical Wounds, Thin-gingiva, Strip graft, Free gingival graft, Peri-implant keratinized mucosa, Soft tissue augmentation