Alveolar Ridge Preservation With Different Grafting Strategies

Comparison of Half- and Full-Grafting Alveolar Ridge Preservation With Different Sealing Materials: A Three-arm Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Bone Resorption
• Intervention / Treatment: Procedure: Alveolar ridge preservation

Detailed Description

Regarding different surgical approaches in alveolar ridge preservation, limited studies directly compare collagen and non-resorbable membrane, and the comparison between half- and full- grafting strategy in clinical and radiographic outcomes was still lacking. The comparable effect of dimensional preservation between groups was shown except for more radiographic bone gain in full-grafting group. Contributing factors, including thin bone thickness , vertical root fracture related sockets, non-molar sites and large BPD might attenuate the effect of ARP. At implant placement, similar results in bone quality and keratinized mucosal width was found in all groups, while thicker vertical mucosal thickness was obtained when using nonresorbable membrane. All surgical modalities in alveolar ridge preservation yield stable peri-implant health 1 year after implant placement.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 105
    • Taipei Chang Gung Memorial hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. ≥ 20 years old
2. 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
3. the extraction socket should have more than two walls for ARP, which includes type I-II sockets (Palatal/ lingual defects were also included)
4. 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).

Exclusion Criteria:

1. heavy smokers consuming more than half pack of cigarettes daily
2. women who were pregnant, lactating, or planning to be pregnant
3. history of psychiatric disorders
4. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test1; 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; Different grafting strategy of alveolar ridge preservation with different sealing materials
Experimental: Test2; 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; Different grafting strategy of alveolar ridge preservation with different sealing materials
Experimental: Control; full-grafting (DBBM-C+ Collagen membrane) in tooth sockets	Procedure: Alveolar ridge preservation; Different grafting strategy of alveolar ridge preservation with different sealing materials

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical and implant related outcomes	Other clinical and implant-related parameters with descriptions: Demographic data; Keratinized mucosal width (KMW)(mm); Vertical mucosal thickness (VMT): measured from the mucosal profile to the crest of the ridge using a periodontal probe after buccal full-thickness flap elevation (Hu-Friedy, Chicago, IL, USA)(mm); Bone density: Lekholm and Zarb's classification as types 1, 2, 3, or 4; Insertion torque: recorded once the implant was placed at the anticipated level with primary stability (NCM); Marginal bone level change(mm) Based on the results of the normality tests, one-way ANOVA followed by the Tukey HSD or Kruskal-Wallis test with post hoc Dunn's test was performed for intergroup comparisons. The Chi-square association test (X2) was used to compare categorical variables between groups. Univariate linear regression methods were performed to investigate the factors to the changes of ridge width and height.	6-month healing period after alveolar ridge preservation

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): March 7, 2023
• Study Completion (Actual): July 12, 2023

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: September 16, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 16, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: dental implants; alveolar ridge preservation; sealing material; resorbable membrane; non-resorbable membrane
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Resorption
• Other Study ID Numbers: Chang Gung MH (CMRPG3H1931)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Raw data were generated at Taipei Chang Gung memorial hospital. Derived data supporting the findings of this study are available from the corresponding author(CYL) on request.

Drug and device information, study documents

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