Back to resultsAlveolar Ridge Preservation With Different Grafting Strategies
Primary Purpose
Bone Resorption
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Alveolar ridge preservation
Sponsored by
About this trial
This is an interventional treatment trial for Bone Resorption focused on measuring alveolar ridge preservation, sealing material, resorbable membrane, non-resorbable membrane, dental implants
Eligibility Criteria
Inclusion Criteria: ≥ 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). Exclusion Criteria: 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.
Sites / Locations
- Taipei Chang Gung Memorial hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Test1
Test2
Control
Arm Description
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
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
full-grafting (DBBM-C+ Collagen membrane) in tooth sockets
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT06049823
First Posted
September 11, 2023
Last Updated
September 16, 2023
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06049823
Brief Title
Alveolar Ridge Preservation With Different Grafting Strategies
Official Title
Comparison of Half- and Full-Grafting Alveolar Ridge Preservation With Different Sealing Materials: A Three-arm Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
March 7, 2023 (Actual)
Study Completion Date
July 12, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Resorption
Keywords
alveolar ridge preservation, sealing material, resorbable membrane, non-resorbable membrane, dental implants
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test1
Arm Type
Experimental
Arm Description
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
Arm Title
Test2
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Experimental
Arm Description
full-grafting (DBBM-C+ Collagen membrane) in tooth sockets
Intervention Type
Procedure
Intervention Name(s)
Alveolar ridge preservation
Intervention Description
Different grafting strategy of alveolar ridge preservation with different sealing materials
Primary Outcome Measure Information:
Title
bone dimensional changes between the groups
Description
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).
Time Frame
6-month healing period after alveolar ridge preservation
Secondary Outcome Measure Information:
Title
Clinical and implant related outcomes
Description
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.
Time Frame
6-month healing period after alveolar ridge preservation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
≥ 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).
Exclusion Criteria:
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.
Facility Information:
Facility Name
Taipei Chang Gung Memorial hospital
City
Taipei
ZIP/Postal Code
105
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing 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.
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Alveolar Ridge Preservation With Different Grafting Strategies
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