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Connective Tissue Graft Versus Collagen Matrix

NCT04210596 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-03-06

No results posted yet for this study

Summary

Patients in need of a single implant in the premaxilla and presenting with a horizontal buccal soft tissue defect at the single tooth gap will be invited to participate in a multicenter RCT. Prior to surgery, a small-field low-dose CBCT is taken since a buccopalatal bone dimension of at least 6 mm at the central and crestal aspect of the single tooth gap is required to ensure complete embedding of an implant by bone. Sixty patients will be randomly allocated to the test group or control group in 6 centers. Each center receives 10 sealed envelopes (5 are internally labelled with 'test group' and 5 with 'control group').

For each patient a digital planning is performed in implant planning software and a tooth-supported surgical guide is fabricated. In the control group, a single implant is placed following flap elevation and surgical guide installation. Then, a CTG from the palate is positioned under the buccal mucosa to thicken the tissues. A provisional restoration is placed at the day of surgery, which is replaced by a permanent one 3m later. Patients in the test group are treated in the same way, yet a CM (Fibro-Gide®) is used instead of a CTG.

Changes in the buccal soft tissue profile are registered over time by superimposing intra-oral scans in SMOP® software.

Secondary outcomes included clinical, aesthetic and patient-reported outcomes.

Conditions

  • Buccal Soft Tissue Profile (BSP)

Interventions

PROCEDURE

Soft tissue augmentation at the buccal aspect of single implants

Soft tissue augmentation is performed following mucoperiosteal flap elevation at the buccal aspect of single implants. The connective tissue graft (control) or collagen matrix (test) is inserted in the buccal pouch and attached with monofilament sutures.

Sponsors & Collaborators

  • Osteology Foundation

    collaborator OTHER

  • University Ghent

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04210596 on ClinicalTrials.gov