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NCT Number: NCT07371481

CTG Versus Collagen Matrix for Peri-Implant Soft Tissue Augmentation

This randomized controlled trial compares two techniques for peri-implant soft tissue augmentation in the mandibular molar region: an autogenous connective tissue graft (CTG) and a collagen matrix. Adult patients requiring implant treatment with insufficient peri-implant soft tissue thickness will be randomly assigned to receive either CTG or a collagen matrix at the time of implant surgery.

The study aims to evaluate and compare changes in peri-implant soft tissue thickness, width of keratinized tissue, and soft tissue contour over a 9-month follow-up period, as well as the occurrence of postoperative complications. The results of this study will help determine whether a collagen matrix can provide clinical outcomes comparable to those of connective tissue grafting for peri-implant soft tissue augmentation.

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Key information

Conditions

Peri-implant Soft Tissue Deficiency Insufficient Peri-implant Keratinized Tissue

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hanoi Medical University

Hanoi, Vietnam

About this study

This randomized controlled trial is designed to compare two approaches for peri-implant soft tissue augmentation in the mandibular molar region: an autogenous connective tissue graft (CTG) and a collagen matrix. Adult patients with insufficient peri-implant soft tissue thickness will be enrolled and randomly allocated in a 1:1 ratio to receive either CTG or a collagen matrix at the time of implant surgery. Randomization will be performed using a block randomization method, and outcome assessment will be conducted by a blinded examiner.

Clinical and digital evaluations will be performed at predefined time points, including baseline and follow-up visits up to 9 months after surgery. Peri-implant soft tissue thickness, width of keratinized tissue, and soft tissue contour changes will be assessed using standardized clinical measurements and digital workflows based on intraoral scanning and cone-beam computed tomography where indicated. Postoperative healing and adverse events will be monitored throughout the follow-up period.

The study is conducted at a single academic center and is intended to provide comparative clinical data on the effectiveness and safety of collagen matrix versus connective tissue grafting for peri-implant soft tissue augmentation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults aged 18 to 65 years.

Patients requiring dental implant treatment in the mandibular molar region.

Presence of insufficient peri-implant soft tissue thickness (< 2 mm).

Adequate general health to undergo minor oral surgery.

Ability and willingness to provide written informed consent and comply with study procedures.

Exclusion criteria

Systemic conditions or medications that may impair wound healing.

Heavy smoking (more than 10 cigarettes per day).

History of allergy or hypersensitivity to collagen-based materials.

Previous graft failure or complications at the intended implant site.

Loss of three or more adjacent teeth in the study area (excluding third molars).

Treatment and study plan

Collagen Matrix

Device

A porcine-derived collagen matrix is used for peri-implant soft tissue augmentation at the time of implant surgery, serving as a substitute for autogenous connective tissue grafting.

connective tissue graft

Procedure

An autogenous connective tissue graft harvested from the patient is used for peri-implant soft tissue augmentation at the time of implant surgery.

Primary outcomes

  1. Change in peri-implant soft tissue thickness

    Time frame: Baseline (before surgery) to 9 months after surgery

    Change in peri-implant soft tissue thickness measured using standardized digital methods.

Secondary outcomes

  1. Change in width of peri-implant keratinized tissue

    Time frame: Baseline to 9 months after surgery

    Change in the width of keratinized tissue around the implant measured clinically using standardized procedures.

  2. Change in peri-implant marginal bone level

    Time frame: Baseline to 9 months after surgery

    Changes in marginal bone level assessed using cone-beam computed tomography where indicated.

  3. Peri-implant clinical indices

    Time frame: Up to 9 months after surgery

    Assessment of peri-implant inflammation using standardized clinical indices.

Other outcomes

  1. Postoperative complications and adverse events

    Time frame: Up to 9 months after surgery

    Incidence of postoperative complications, including soft tissue necrosis, infection, bleeding, implant failure, and other adverse events.

Study contacts

Contact information is provided by the study sponsor or research team.

Phu Manh Nguyen, DDS, MSc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Hanoi Medical University

Other

Registry information

Official study title

Results of Soft Tissue Grafting Around Implant in the Mandible Molar Area

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 28, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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