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Contour Augmentation by Means of Connective Tissue Grafting Versus Guided Bone Regeneration

NCT05143242 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-12-03

No results posted yet for this study

Summary

The most frequent aesthetic complication following single implant treatment seems to be a lack of buccal convexity. This 'alveolar process deficiency' is the result of buccal bone remodeling following tooth extraction.

A traditional approach to treat alveolar process deficiency is guided bone regeneration (GBR), however post-operative complications such as swelling, bleeding and pain are common and the aesthetic outcome may not be optimal.

An alternative to the traditional GBR approach could be soft tissue contour augmentation using a connective tissue graft (CTG) at the buccal aspect. Possible advantages over GBR include less morbidity at the implant site, a superior aesthetic outcome since there is no need for vertical releasing incisions and less costs since there are no biomaterials to be used.

The primary study objective is to compare the GBR and CTG group in terms of 2 and 3 dimensional tissue alterations, focusing on the amount of tissue gain and volume stability over time. The secondary study objectives are morbidity, overall radiographic, clinical and aesthetic outcomes.

Conditions

  • Guided Bone Regeneration

Interventions

PROCEDURE

Hard tissue augmentation at the buccal aspect of single implants.

One or two releasing incisions are made. The periosteum is released and multiple bone perforations are made in the buccal bone prior to the application of deproteinized bovine derived xenograft. A Creos® membrane (Nobel Biocare, Gothenburg, Sweden) is used to cover the occlusal part of the alveolar crest and the xenograft particles. Finally, multiple single monofilament sutures are used for primary tension-free wound closure.

PROCEDURE

Soft tissue augmentation at the buccal aspect of single implants.

A CTG is taken from the palate and transplanted to the buccal side between the alveolar bone and the buccal flap. The CTG is secured with single monofilament sutures.

Sponsors & Collaborators

  • University Ghent

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2020-03-31
Completion
2021-04-30

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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 NCT05143242 on ClinicalTrials.gov