Alveolar Ridge Preservation With Different Grafting Strategies

NCT06049823 | Completed DMC

• 1 other identifier: Chang Gung MH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study was to compare the half-packed grafts that are covered with either a collagen or a nonresorbable membrane to the conventional alveolar ridge preservation procedures involving full-packed grafts and collagen membrane. The primary purpose was to evaluate the bone dimensional changes between the groups, and the secondary objective was to assess the potential contributing factors to clinical, radiographic and implant-related outcomes under different alveolar ridge preservation procedures.

Conditions

Bone Resorption

Keywords

alveolar ridge preservation; sealing material; resorbable membrane; non-resorbable membrane; dental implants

Outcome Measures

Primary Outcomes (1)

• bone dimensional changes between the groups

  Based on CBCT images, horizontal measurements by using AVIZO software (version 7.0, FEI). The measurements were repeated twice at a 2-week interval, and mean values were used for the final analysis (width or height in millimeters, mm): * Buccal bone plate thickness (BT) at 1 mm, 3mm, 5mm apical to the crest * Horizontal ridge width (HRW) at 1 at 1 mm, 3mm, 5mm apical to the crest * The change of HRW at 1, 3, 5 mm apical to crest (T2-T1). Vertical measurements in cross-sectional images: * Buccal bone height (BH)(mm) * Palatal/lingual bone height (PH)(mm) * The discrepancy between buccal and palatal/lingual height.(mm) * Midcrestal height (Mid-H)(mm) * The change of BH, PH, and Mid-H between immediate post-operative and 6 months later. (T2-T1)(mm).

  6-month healing period after alveolar ridge preservation

Secondary Outcomes (1)

• Clinical and implant related outcomes

  6-month healing period after alveolar ridge preservation

Study Arms (3)

Test1

EXPERIMENTAL

half- (bottom 50% of socket filled with gelatin sponge and the top 50% of the socket filled with deproteinized bovine bone mineral mixed with collagen (DBBM-C)) then covered with a collagen membrane in tooth sockets

Procedure: Alveolar ridge preservation

Test2

EXPERIMENTAL

half- (bottom 50% of socket filled with gelatin sponge and the top 50% of the socket filled with deproteinized bovine bone mineral mixed with collagen (DBBM-C)) then covered with a nonresorbable membrane in tooth sockets

Procedure: Alveolar ridge preservation

Control

EXPERIMENTAL

full-grafting (DBBM-C+ Collagen membrane) in tooth sockets

Procedure: Alveolar ridge preservation

Interventions

Alveolar ridge preservation PROCEDURE

Different grafting strategy of alveolar ridge preservation with different sealing materials

Control; Test1; Test2

Eligibility Criteria

• Age: 24 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 20 years old
• presence of one or more hopeless teeth requiring extraction and subsequent implant placement due to reasons such as crack tooth, vertical root fracture, endodontic failure, unrestorable caries and severe periodontitis
• the extraction socket should have more than two walls for ARP, which includes type I-II sockets (Palatal/ lingual defects were also included)
• participants should have a stable periodontal condition or history of periodontitis that is well-controlled with good oral hygiene. The pocket depth of the adjacent tooth around the socket should be less than 3 mm as assessed with a periodontal probe (Hu-Friedy, Chicago, IL, USA).

You may not qualify if:

• heavy smokers consuming more than half pack of cigarettes daily
• women who were pregnant, lactating, or planning to be pregnant
• history of psychiatric disorders
• uncontrolled and complicated medical conditions that might hinder wound healing or bone metabolism, including poorly controlled diabetes, autoimmune disorders, receiving current radiotherapy in the head and neck regions, taking bisphosphonate and other antiresorptive agents.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Taipei Chang Gung Memorial hospital

Taipei, 105, Taiwan

Location

Related Publications (2)

• Hsieh CH, Kuo PY, Chiu MY, Lin CY. The Effectiveness of Different Grafting Strategies in Alveolar Ridge Preservation: A Retrospective Study of Two- and Three- Dimensional Radiographic Analysis. Int J Oral Maxillofac Implants. 2026 Jan 12;0(0):1-38. doi: 10.11607/jomi.11369. Online ahead of print.

  PMID: 41525719 DERIVED

• Lin CY, Chiu MY, Kuo PY, Wang HL. Half- and full-grafting alveolar ridge preservation with different sealing materials: A three-arm randomized clinical trial. Clin Implant Dent Relat Res. 2024 Jun;26(3):651-662. doi: 10.1111/cid.13327. Epub 2024 Apr 18.

  PMID: 38638057 DERIVED

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The operator (L.C.Y.) was blinded to the assignment and opened the envelope just before the alveolar ridge preservation procedures, while both the participants and the examiners (C.M.Y., P.Y.K.) remained completely blinded to the assignments in the study protocol.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistent professor

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 22, 2023
• Study Start: May 10, 2021
• Primary Completion: March 7, 2023
• Study Completion: July 12, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

TW (1)