Alveolar Ridge Preservation With Different Grafting Strategies

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06049823
Collaborator
(none)
60
1
3
26.1
2.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Alveolar ridge preservation
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Treatment
Official Title:
Comparison of Half- and Full-Grafting Alveolar Ridge Preservation With Different Sealing Materials: A Three-arm Randomized Clinical Trial
Actual Study Start Date :
May 10, 2021
Actual Primary Completion Date :
Mar 7, 2023
Actual Study Completion Date :
Jul 12, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. bone dimensional changes between the groups [6-month healing period after alveolar ridge preservation]

    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).

Secondary Outcome Measures

  1. Clinical and implant related outcomes [6-month healing period after alveolar ridge preservation]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
24 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taipei Chang Gung Memorial hospital Taipei Taiwan 105

Sponsors and Collaborators

  • Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Choying Lin, assistent professor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT06049823
Other Study ID Numbers:
  • Chang Gung MH
First Posted:
Sep 22, 2023
Last Update Posted:
Sep 22, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Choying Lin, assistent professor, Chang Gung Memorial Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 22, 2023