Ridge Preservation Using Different Techniques

Soft Tissue Contour and Radiographic Evaluation of Ridge Preservation Using Different Techniques

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Tooth Extraction; Alveolar Ridge Augmentation; Connective Tissue; Membranes; Retained
• Intervention / Treatment: Procedure: Alveolar ridge preservation; Procedure: Alveolar ridge preservation; Procedure: Alveolar ridge preservation; Procedure: Alveolar ridge preservation

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 114202
    • Tri-Service General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: spontaneous healing; No treatment after tooth extraction
Experimental: Bone particle + subepithelial connective tissue graft; Alveolar ridge preservation grafted with bone particle and covered with a subepithelial connective tissue graft	Procedure: Alveolar ridge preservation; grafted with bone particle and covered with a subepithelial connective tissue graft; Procedure: Alveolar ridge preservation; grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft; Procedure: Alveolar ridge preservation; grafted with bone particle and covered with a collagen membrane; Procedure: Alveolar ridge preservation; grafted with bone particle and covered with a Cytoplast
Experimental: Bone particle + Vascularized interpositional periosteal connective tissue graft; Alveolar ridge preservation grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft	Procedure: Alveolar ridge preservation; grafted with bone particle and covered with a subepithelial connective tissue graft; Procedure: Alveolar ridge preservation; grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft; Procedure: Alveolar ridge preservation; grafted with bone particle and covered with a collagen membrane; Procedure: Alveolar ridge preservation; grafted with bone particle and covered with a Cytoplast
Experimental: Bone particle + collagen membrane; Alveolar ridge preservation grafted with bone particle and covered with a collagen membrane	Procedure: Alveolar ridge preservation; grafted with bone particle and covered with a subepithelial connective tissue graft; Procedure: Alveolar ridge preservation; grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft; Procedure: Alveolar ridge preservation; grafted with bone particle and covered with a collagen membrane; Procedure: Alveolar ridge preservation; grafted with bone particle and covered with a Cytoplast
Experimental: Bone particle + Cytoplast; Alveolar ridge preservation grafted with bone particle and covered with a Cytoplast.	Procedure: Alveolar ridge preservation; grafted with bone particle and covered with a subepithelial connective tissue graft; Procedure: Alveolar ridge preservation; grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft; Procedure: Alveolar ridge preservation; grafted with bone particle and covered with a collagen membrane; Procedure: Alveolar ridge preservation; grafted with bone particle and covered with a Cytoplast

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tri-Service General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: May 26, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Tooth extraction; Membranes; Alveolar Ridge Preservation Connective tissue graft
• Other Study ID Numbers: A202305015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No