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Extraction Socket Management Using Connective Tissue Graft Versus Mucograft®

NCT02753153 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2016-04-27

No results posted yet for this study

Summary

This study aims at assessing the hard and soft tissues remodelling of the alveolar crest after extraction socket managements in the aesthetic areas:

* 3D radiographic evaluation (CT scan) was performed post extraction and 3 months after at the time of implant placement. (Outcomes 1: Hard tissues analyses )
* Impressions, models and 3D analyses of the treated area allowed studying external soft tissue remodeling at different time points after extraction. (Outcomes 2: Soft tissues analyses )

Conditions

  • Tooth Lost

Interventions

PROCEDURE

Control surgical protocol

A connective tissue graft will be harvested to the palate or posterior maxilla tuberosity. The dimension of the graft will be previously calculated according to the socket dimensions. The harvesting site will be made with a single edge incision and sutured with 4.0 silk (uninterrupted suture). The connective tissue graft will be reshaped if necessary to be 1-2mm thick and inserted into buccal pouch and sutured with 2 vertical interrupted sutures to be stabilized on the buccal aspect. The connective tissue graft is then positioned to caver the socket and inserted and sutured in the palatal pouch also by the means of vertical interrupted sutures (polypropylen 6.0).

PROCEDURE

Test surgical protocol

The filling biomaterial (Bio-Oss®, Geistlich), previously humidified with a saline solution containing doxycycline (1mg/ml) and inserted into the socket without heavy compaction.

PROCEDURE

Socket preservation

An atraumatic extraction will be performed in order to preserve the socket bone wall as well as the cervical soft tissues. Split- thickness pockets will be performed 5-6 mm deep buccally and 3-4 mm deep palatally preserving interproximal papillae. The filling biomaterial (Bio-Oss®, Geistlich), previously humidified with a saline solution containing doxycycline (1mg/ml) and inserted into the socket without heavy compaction. At this level of the surgery, the randomization envelope will be open and either the control or the test surgical protocol will be applied.

Sponsors & Collaborators

  • University of Liege

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2015-05-31
Completion
2015-05-31

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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 NCT02753153 on ClinicalTrials.gov