Ridge Preservation Using Different Techniques

NCT05892016 | Enrolling By Invitation

• 1 other identifier: A202305015
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Alveolar Ridge Preservation Connective tissue graft; Tooth extraction; Membranes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Keratinized tissue width changes

  up to 12 months

• Visual Analogue Scale

  14 days

Study Arms (5)

spontaneous healing

NO INTERVENTION

No treatment after tooth extraction

Bone particle + subepithelial connective tissue graft

EXPERIMENTAL

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

Procedure: Alveolar ridge preservation

Bone particle + Vascularized interpositional periosteal connective tissue graft

EXPERIMENTAL

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

Procedure: Alveolar ridge preservation

Bone particle + collagen membrane

EXPERIMENTAL

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

Procedure: Alveolar ridge preservation

Bone particle + Cytoplast

EXPERIMENTAL

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

Procedure: Alveolar ridge preservation

Interventions

Alveolar ridge preservation PROCEDURE

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

Bone particle + Cytoplast; Bone particle + Vascularized interpositional periosteal connective tissue graft; Bone particle + collagen membrane; Bone particle + subepithelial connective tissue graft

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, 114202, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: 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.

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: June 7, 2023
• Study Start: February 28, 2023
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: June 7, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)