Ridge Preservation Using Different Techniques

NCT ID: NCT05892016

Last Updated: 2023-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-28

Study Completion Date

2026-03-31

Brief Summary

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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

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Conditions

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Alveolar Ridge Augmentation Connective Tissue Tooth Extraction Membranes; Retained

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1. spontaneous healing (control) Alveolar ridge preservation grafted with bone particle and
2. covered with a free palatal graft
3. covered with pedical palatal graft
4. covered with a collagen membrane
5. covered with a non-resorbable high-density polytetrafluoroethylene membrane.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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spontaneous healing

No treatment after tooth extraction

Group Type NO_INTERVENTION

No interventions assigned to this group

Bone particle + subepithelial connective tissue graft

Alveolar ridge preservation grafted with bone particle and covered with a subepithelial connective tissue graft

Group Type EXPERIMENTAL

Alveolar ridge preservation

Intervention Type PROCEDURE

grafted with bone particle and covered with a subepithelial connective tissue graft

Alveolar ridge preservation

Intervention Type PROCEDURE

grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft

Alveolar ridge preservation

Intervention Type PROCEDURE

grafted with bone particle and covered with a collagen membrane

Alveolar ridge preservation

Intervention Type PROCEDURE

grafted with bone particle and covered with a Cytoplast

Bone particle + Vascularized interpositional periosteal connective tissue graft

Alveolar ridge preservation grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft

Group Type EXPERIMENTAL

Alveolar ridge preservation

Intervention Type PROCEDURE

grafted with bone particle and covered with a subepithelial connective tissue graft

Alveolar ridge preservation

Intervention Type PROCEDURE

grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft

Alveolar ridge preservation

Intervention Type PROCEDURE

grafted with bone particle and covered with a collagen membrane

Alveolar ridge preservation

Intervention Type PROCEDURE

grafted with bone particle and covered with a Cytoplast

Bone particle + collagen membrane

Alveolar ridge preservation grafted with bone particle and covered with a collagen membrane

Group Type EXPERIMENTAL

Alveolar ridge preservation

Intervention Type PROCEDURE

grafted with bone particle and covered with a subepithelial connective tissue graft

Alveolar ridge preservation

Intervention Type PROCEDURE

grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft

Alveolar ridge preservation

Intervention Type PROCEDURE

grafted with bone particle and covered with a collagen membrane

Alveolar ridge preservation

Intervention Type PROCEDURE

grafted with bone particle and covered with a Cytoplast

Bone particle + Cytoplast

Alveolar ridge preservation grafted with bone particle and covered with a Cytoplast.

Group Type EXPERIMENTAL

Alveolar ridge preservation

Intervention Type PROCEDURE

grafted with bone particle and covered with a subepithelial connective tissue graft

Alveolar ridge preservation

Intervention Type PROCEDURE

grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft

Alveolar ridge preservation

Intervention Type PROCEDURE

grafted with bone particle and covered with a collagen membrane

Alveolar ridge preservation

Intervention Type PROCEDURE

grafted with bone particle and covered with a Cytoplast

Interventions

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Alveolar ridge preservation

grafted with bone particle and covered with a subepithelial connective tissue graft

Intervention Type PROCEDURE

Alveolar ridge preservation

grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft

Intervention Type PROCEDURE

Alveolar ridge preservation

grafted with bone particle and covered with a collagen membrane

Intervention Type PROCEDURE

Alveolar ridge preservation

grafted with bone particle and covered with a Cytoplast

Intervention Type PROCEDURE

Eligibility Criteria

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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.

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).
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tri-Service General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Cheng-En Sung

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tri-Service General Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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A202305015

Identifier Type: -

Identifier Source: org_study_id

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