NCT07371481

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
31mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Feb 2026Dec 2028

First Submitted

Initial submission to the registry

January 19, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

1.8 years

First QC Date

January 19, 2026

Last Update Submit

January 27, 2026

Conditions

Peri-implant Soft Tissue DeficiencyInsufficient Peri-implant Keratinized Tissue

Keywords

Peri-implant soft tissue augmentationConnective tissue graftCollagen matrixDental implant

Outcome Measures

Primary Outcomes (1)

  • Change in peri-implant soft tissue thickness

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

    Baseline (before surgery) to 9 months after surgery

Secondary Outcomes (3)

  • Change in width of peri-implant keratinized tissue

    Baseline to 9 months after surgery

  • Change in peri-implant marginal bone level

    Baseline to 9 months after surgery

  • Peri-implant clinical indices

    Up to 9 months after surgery

Other Outcomes (1)

  • Postoperative complications and adverse events

    Up to 9 months after surgery

Study Arms (2)

Connective Tissue Graft (CTG)

ACTIVE COMPARATOR

Peri-implant soft tissue augmentation using autogenous connective tissue graft.

Procedure: Connective Tissue Graft

Collagen Matrix

EXPERIMENTAL

Peri-implant soft tissue augmentation using a collagen matrix.

Device: Collagen Matrix

Interventions

Collagen MatrixDEVICE

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.

Collagen Matrix
Connective Tissue GraftPROCEDURE

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

Connective Tissue Graft (CTG)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanoi Medical University

Hanoi, Vietnam

Location

Central Study Contacts

Phu Manh Nguyen, DDS, MSc

CONTACT

manhphu@hmu.edu.vn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessment is performed by an independent examiner who is blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned in a 1:1 ratio to one of two parallel groups to receive either a connective tissue graft or a collagen matrix for peri-implant soft tissue augmentation, with no crossover between groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS

Study Record Dates

First Submitted

January 19, 2026

First Posted

January 28, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the dataset contains sensitive clinical and imaging information, and data sharing was not included in the approved study protocol or informed consent.

Locations

VN(1)