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Soft Tissue Changes Around Dental Implants

NCT04265768 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-06-08

No results posted yet for this study

Summary

This study aims to characterize the healing pattern following soft tissue augmentation procedure concomitant to implant placement.

Conditions

  • Tooth Loss
  • Dental Diseases
  • Wound Heal

Interventions

PROCEDURE

Soft tissue augmentation surgery with CTG

An epithelial-connective tissue graft of approximately 2-3 mm of thickness and adequate length will be taken from the palate or retromolar region of the patient and de-epithelialized with a scalpel (ideally a thickness of 1.5-2.0mm). The connective tissue graft (CTG) obtained will then be positioned buccally to the dental implant and sutured to the internal side of the flap so to provide soft tissue bulk at the level of the neck of the implant and simulate a root prominence for the missing tooth.

PROCEDURE

Soft tissue augmentation surgery with Fibro-Gide

Fibro-Gide will be used to obtain buccal soft tissue augmentation. Fibro-Gide will be trimmed with a scalpel and adjusted in size and thickness to better adapt to the area buccal to the implant. In particular, the graft will be shaped in order to obtain a graft of approximately 2-3 mm of thickness and adequate length. Fibro-Gide will then be sutured to the inner side of the buccal flap, before repositioning the flap and suturing it in a tension-free way.

PROCEDURE

No soft tissue augmentation

During implant placement surgery, no soft tissue augmentation will be performed

Sponsors & Collaborators

  • Geistlich Pharma AG

    collaborator INDUSTRY

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Nikos Donos, PhD · Barts & The London School of Medicine & Dentistry, QMUL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-21
Primary Completion
2025-02-24
Completion
2025-02-24

Countries

  • United Kingdom

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 NCT04265768 on ClinicalTrials.gov