NCT07024186

Xenogenic Collagen Matrix vs. Connective Tissue Graft for Soft Tissue Augmentation Around Early Maxillary Implants

Soft Tissue Augmentation by Xenogenic Collagen Matrix Versus Sub Epithelial Connective Tissue Graft Around Early Implant Placement in Maxillary Esthetic Zone

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Minia University · Academic / Other
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study compares two methods used to improve gingival tissue around dental implants placed in (the maxillary esthetic zone). After a tooth is removed and a dental implant is placed early (usually 4-8 weeks later), additional soft tissue is sometimes needed to ensure the implant looks natural and functions well. The two techniques being studied are: Subepithelial connective tissue graft (SCTG) - where tissue is taken from the patient's own mouth (usually the palate) Xenogeneic collagen matrix (XCM) - a processed collagen material from animals, used as a substitute for the patient's own tissue. The goal is to see which method is better in terms of gingival thickness, esthetic appearance, healing, and patient comfort. This research may help dentists choose the most effective and comfortable treatment for their patients.

Detailed description

Dental implants in the anterior maxillary region (esthetic zone) are commonly used to replace missing teeth. When implants are placed using the early placement protocol (typically 4-8 weeks after tooth extraction), additional soft tissue volume may be required to ensure an esthetically pleasing and functionally stable result. Soft tissue augmentation can be achieved using: Subepithelial connective tissue grafts (SCTG): A technique that involves harvesting tissue from the patient's own palate and placing it around the implant to improve gingival thickness and contour. Xenogeneic collagen matrix (XCM): A biocompatible, animal-derived collagen scaffold designed to substitute for autologous tissue, reducing patient morbidity and surgical time. This study is a prospective, randomized, controlled, parallel-arm clinical trial conducted at Minia University, Faculty of Dentistry. Eligible patients missing a single tooth in the anterior maxilla with a thin gingival biotype and requiring early implant placement were recruited. A total of 20 patients were randomly assigned into two groups (10 per group): Group 1 (Control): Received subepithelial connective tissue graft harvested from the palate using the single-incision technique. Group 2 (Test): Received xenogeneic collagen matrix (Mucoderm®) adapted and inserted into the grafting site. Outcome Measures: Primary Outcome: Change in gingival thickness (GT) at 12 months post-surgery, measured via transgingival probing using a standardized protocol. Secondary Outcomes: Change in width of keratinized tissue (KTW) Esthetic outcome (using clinical photographs and standardized scoring systems, e.g., Pink Esthetic Score) Post-operative healing and complications Patient-reported outcomes regarding comfort, pain, and satisfaction (using Visual Analog Scale questionnaires) Clinical and radiographic assessments were performed at baseline, 6 months, and 12 months post-implant placement. Ethical approval was obtained from the Research Ethics Committee of Minia University, and all participants provided informed consent. The study adheres to the Declaration of Helsinki and ICH-GCP guidelines. This research aims to provide evidence on whether xenogeneic collagen matrix can serve as a viable, less invasive alternative to autogenous tissue grafts in implant dentistry, especially for cases with esthetic demand and thin soft tissue biotype.

Conditions

• Alveolar Bone Loss
• Gingival Recession
• Peri-implant Mucositis

Interventions

Type	Name	Description
PROCEDURE	Xenogeneic Collagen Matrix	Xenogeneic Collagen Matrix The xenogeneic collagen matrix is a biomaterial used to promote soft tissue regeneration and support healing in dental implant procedures.
PROCEDURE	subepithelial connective tissue graft	ubepithelial Connective Tissue Graft The subepithelial connective tissue graft is a biological tissue taken from the patient's own palate or other donor sites to promote healing and aesthetic outcomes around dental implants.

Timeline

• Start date: 2022-03-17
• Primary completion: 2024-11-08
• Completion: 2025-02-20
• First posted: 2025-06-17
• Last updated: 2025-06-17

Locations

1 site across 1 country: Egypt