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

NCT07024186 | Completed DMC

• 1 other identifier: Study ID: 505-2021
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alveolar Bone Loss; Gingival Recession; Peri-implant Mucositis

Keywords

Xenogenic Collagen Matrix; Connective Tissue Graft; Soft Tissue Augmentation

Outcome Measures

Primary Outcomes (1)

• Peri-implant soft tissue thickness

  change in soft tissue thickness measured in millimeters at the buccal aspect of the implant site.

  12 months after implant placement

Study Arms (2)

Xenogeneic Collagen Matrix

ACTIVE COMPARATOR

This arm involves the use of a xenogeneic collagen matrix for soft tissue augmentation around early implant placement in the maxillary esthetic zone.

Procedure: Xenogeneic Collagen Matrix

Subepithelial Connective Tissue Graft

ACTIVE COMPARATOR

This arm involves the use of a subepithelial connective tissue graft for soft tissue augmentation around early implant placement in the maxillary esthetic zone.

Procedure: subepithelial connective tissue graft

Interventions

Xenogeneic Collagen Matrix PROCEDURE

Xenogeneic Collagen Matrix The xenogeneic collagen matrix is a biomaterial used to promote soft tissue regeneration and support healing in dental implant procedures.

Xenogeneic Collagen Matrix

subepithelial connective tissue graft PROCEDURE

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.

Subepithelial Connective Tissue Graft

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Non-restorable or hopeless teeth from maxillary anterior to first premolar due to one or more of the following:
• Extensive caries
• Root fractures
• Inability to perform functional crown lengthening due to gingival zenith line with high gingival display
• Improper crown-to-root ratio due to bone removal leading to aesthetic or restorative failure
• Patients aged 25-55 years
• Both male and female patients
• Thin tissue biotype

You may not qualify if:

• Pregnant women
• Smokers
• Presence of persistent chronic infection at the implant site
• Patients in the growth phase with partially erupted teeth
• Patients with parafunctional habits such as bruxism or clenching that may overload the implant
• Patients with insufficient vertical inter-arch space in centric occlusion to accommodate restorative components

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minya

Minya, Minya Governorate, 61519, Egypt

Location

MeSH Terms

Conditions

Alveolar Bone Loss; Gingival Recession

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases

Study Officials

• Mohamed O Ismail, MSc

  Faculty of Dentistry, Minia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor responsible for evaluating soft tissue volume and esthetic results is blinded to the group allocation to reduce assessment bias. Participants and care providers are not blinded due to the nature of the surgical interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate, Faculty of Dentistry

Model Details: Participants are assigned in parallel to either the xenogeneic collagen matrix group or the subepithelial connective tissue graft group for soft tissue augmentation around early implant placement in the maxillary esthetic zone. Group allocation is determined by simple randomization using a coin toss.

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: June 17, 2025
• Study Start: March 17, 2022
• Primary Completion: November 8, 2024
• Study Completion: February 20, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

EG (1)