Ridge Preservation Using Different Techniques

Tooth Extraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05892016
• Other study ID #: A202305015
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 28, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: May 2023
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 130
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Alveolar Ridge Augmentation
• Connective Tissue
• Membranes; Retained
• Tooth Extraction

Intervention

Procedure:
• Alveolar ridge preservation
grafted with bone particle and covered with a subepithelial connective tissue graft
• Alveolar ridge preservation
grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft
• Alveolar ridge preservation
grafted with bone particle and covered with a collagen membrane
• Alveolar ridge preservation
grafted with bone particle and covered with a Cytoplast

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soft tissue alternation	cone-beam computed tomography data and STereoLithography files are superimposed to measure the soft tissue dimensions.	up to 12 months
Primary	Hard tissue alternation	cone-beam computed tomography data and STereoLithography files are superimposed to measure the hard tissue dimensions.	up to 12 months
Secondary	Keratinized tissue width changes	Use periodontal probe to measurement.	up to 12 months
Secondary	Visual Analogue Scale	Ask the patient to fill out the questionnaire	14 days