Bone ResorptionNCT06049823
Alveolar Ridge Preservation With Different Grafting Strategies
A study testing Alveolar ridge preservation in people with Bone Resorption, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Resorption
- What is being tested?
- Alveolar ridge preservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 May 2021to 12 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bone Resorption
- Being tested
- Alveolar ridge preservation
- Keywords
- alveolar ridge preservation, sealing material, resorbable membrane, non-resorbable membrane, dental implants
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar ridge preservationProcedure or surgery
Different grafting strategy of alveolar ridge preservation with different sealing materials
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Alveolar ridge preservation |
| Control | Experimental | full-grafting (DBBM-C+ Collagen membrane) in tooth sockets Receives: Procedure: Alveolar ridge preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6-month healing period after alveolar ridge preservation
Secondary outcomes (1)
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.
Measured: 6-month healing period after alveolar ridge preservation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start10 May 2021
- Primary completion7 Mar 2023
- Study completion12 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone ResorptionStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Choying Lin, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049823
- Sponsor's protocol ID
- Chang Gung MH
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 38638057
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Half- and Full-Grafting Alveolar Ridge Preservation With Different Sealing Materials: A Three-arm Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06049823
- Acronym / sponsor ID
- Chang Gung MH
- Conditions
- Bone Resorption
- Keywords
- alveolar ridge preservation, sealing material, resorbable membrane, non-resorbable membrane, dental implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test1 | Experimental | Procedure: Alveolar ridge preservationhalf- (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 |
| Test2 | Experimental | Procedure: Alveolar ridge preservationhalf- (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 |
| Control | Experimental | Procedure: Alveolar ridge preservationfull-grafting (DBBM-C+ Collagen membrane) in tooth sockets |
Who may qualify
- Ages
- 24 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alveolar ridge preservationDifferent grafting strategy of alveolar ridge preservation with different sealing materials | Procedure or surgery | Control, Test1, Test2 |
Primary outcome
bone dimensional changes between the groups
Time frame: 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).
1 secondary outcome
Clinical and implant related outcomes
Time frame: 6-month healing period after alveolar ridge preservation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Derived from this study: PubMed 38638057Lin 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.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alveolar ridge preservation in people with Bone Resorption, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone dimensional changes between the groups (time frame: 6-month healing period after alveolar ridge preservation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06049823, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.