Ridge Preservation Using Different Techniques

Not Applicable

• Conditions: Membranes; Retained; Connective Tissue; Alveolar Ridge Augmentation; Tooth Extraction
• Interventions: Procedure: Alveolar ridge preservation

• Registration Number: NCT05892016
• Lead Sponsor: Tri-Service General Hospital

Brief Summary

Soft tissue contour and radiographic evaluation of alveolar ridge preservation using different techniques

Background:

Following tooth extraction, the alveolar ridge undergoes an inevitable remodeling process which influences future implant therapy or prosthetic rehabilitation in the edentulous area. In an attempt to attenuate the loss of hard and soft tissue after tooth loss, alveolar ridge preservation (ARP) immediately after complete tooth extraction could minimize the need for ancillary ridge augmentation or soft tissue grafting. Different techniques and barrier membranes has been proposed to achieve the sealing of extraction socket.

Aim:

To investigate the effect of different techniques and barrier membranes for the soft tissue contour and morphological change of alveolar ridge after ARP

Methods:

The study was designed as a randomized controlled trial and recruited patients, who require ARP for the purpose of implant placement or prosthodontic rehabilitation. After the tooth extraction, patients were randomly allocated to one of the following groups: ridge preservation with a xenogeneic bone substitute and (a) spontaneous healing (control), (b) covered with a free palatal graft, (c) or covered with pedical palatal graft, (d) covered with a collagen membrane, (e) covered with a non-resorbable high-density polytetrafluoroethylene membrane. 2 weeks, 4 weeks, 12 weeks, and 24 weeks following tooth extraction and ARP, clinical profilometric and radiographic evaluations were performed to analyze the change of hard and soft tissue contour. Moreover, and the need for additional guided bone regeneration (GBR) or soft tissue augmentation were assessed prior implants or fixed prosthesis placement.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-28
• Status Verified: 2023-05
• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-26
• Last Update Submitted: 2023-05-26
• Study First Posted: 2023-06-07
• Last Update Posted: 2023-06-07
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• >20 years old
• No contraindications for invasive dental procedures.
• Not pregnant.
• Teeth need to be extracted due to malocclusion or broken teeth.
• Requires dental implant or denture fabrication after tooth extraction.
• Healthy soft tissue (probing bleeding index <20%, plaque index <20%).
• At least 2mm of keratinized gingiva on the buccal and lingual sides.
• No need for simultaneous bone augmentation surgery during implant placement.
• Willing to participate in and sign the consent form for this trial.

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Exclusion Criteria

• Poor oral hygiene maintenance.
• Uncontrolled periodontal disease.
• Heavy smoker (smokes >20 cigarettes per day).
• Uncontrolled diabetes.
• Alcohol abuse.
• Currently receiving medication treatment affecting wound healing (osteoporosis medication, radiation or chemotherapy).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bone particle + Vascularized interpositional periosteal connective tissue graft	Alveolar ridge preservation	Alveolar ridge preservation grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft
Bone particle + Cytoplast	Alveolar ridge preservation	Alveolar ridge preservation grafted with bone particle and covered with a Cytoplast.
Bone particle + subepithelial connective tissue graft	Alveolar ridge preservation	Alveolar ridge preservation grafted with bone particle and covered with a subepithelial connective tissue graft
Bone particle + collagen membrane	Alveolar ridge preservation	Alveolar ridge preservation grafted with bone particle and covered with a collagen membrane

Primary Outcome Measures

Name	Time	Method
Soft tissue alternation	up to 12 months	cone-beam computed tomography data and STereoLithography files are superimposed to measure the soft tissue dimensions.
Hard tissue alternation	up to 12 months	cone-beam computed tomography data and STereoLithography files are superimposed to measure the hard tissue dimensions.

Secondary Outcome Measures

Name	Time	Method
Keratinized tissue width changes	up to 12 months	Use periodontal probe to measurement.
Visual Analogue Scale	14 days	Ask the patient to fill out the questionnaire

Trial Locations

Locations (1)

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan