Dental ImplantsNCT06742151
Evaluation of the Prevalence Rate and Related Risk Factors of Ridge Preservation
An observational study of Dental Implants, run by Chimei Medical Center.
Trial summary
Treated by dental implant is a well document and popular therapy nowadays. Placement of a dental implant in an ideal three-dimensional position is critical in achieving a predictable long-term success. Read more about this study
- Who is it for?
- Ages 21 to 81 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implants
- What is being tested?
- implant can be placed or not
- Type of treatment
- Surgery or procedure
- How many people
- 133 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2014to 31 Mar 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 21 to 81 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who plan to have single implant surgery from July 2009 to August 2015 were included in this study.
Who may be able to join
- periapical film at the time of tooth extraction
- implant surgery was scheduled within 4 months after tooth extraction.
Who cannot join
- who cannot identify the reason for tooth extraction or unclear periapical film
About this study
Treated by dental implant is a well document and popular therapy nowadays. Placement of a dental implant in an ideal three-dimensional position is critical in achieving a predictable long-term success. However, healing of an extraction socket involves bone remodeling, which inevitably leads to atrophic changes of the alveolar ridge. Studies have shown that most of the resorption occurs during the first 3 months of healing, although dimensional changes can be observed up to 1 year after tooth extraction, resulting in approximately 50% reduction of the bucco-lingual dimension of the alveolar ridge, mainly due to the resorption of the bundle bone plate.
Therefore, the timing of implant placement in extraction sockets can influence the surgery operability and treatment period of time. The classifications of timing of implant placement in extraction sockets as following: Type I: immediate implant placement: implant placement immediately following tooth extraction and as part of the same surgical procedure. Type II: early implant placement: surgery after complete soft tissue coverage of the socket (typically 4~8 weeks).
Read more
Type III: early implant placement: implant surgery after substantial clinical and/or radiographic bone fill of the socket (typically 12~16 weeks). Type IV: late implant placement: surgery at healed site (typically more than 16 weeks). Considering of technique sensitivity and treatment time consuming, early implant placement is the most acceptable clinically.
Many techniques have been developed to maintain the architecture of residual alveolar ridges and regenerative techniques for socket preservation is one of them. This procedure has been widely tested in controlled and uncontrolled studies with various materials and clinical approaches. However, this procedure may require longer treatment period compare to conventional or early implant placement protocol. Meanwhile, there is no study revealed how often and when does socket preservation need to prevent the residual ridge deformity in our daily clinical practice. The aim of the study is try to retrospectively find out the possible advantages and percentage of ridge preservation after tooth extraction in order to understand whether the socket preservation technique is necessary after tooth extraction, and the possible factors which might affect the clinical decision-making.
Read the detailed description
Background:
The alveolar process is a tooth-dependent tissue that develops in conjunction with the eruption of the teeth. The tooth is anchored to the jaws via the bundle bone into which the periodontal ligament fibers invest. Subsequent to the removal of the tooth, the alveolar process will undergo atrophy. The dynamics and magnitude of these changes have been investigated in the dog model as well as in humans. Most of the resorption occurs during the first 3 months of healing, although dimensional changes can be observed up to 1 year after tooth extraction, resulting in approximately 50% reduction of the bucco-lingual dimension of the alveolar ridge, mainly due to the resorption of the bundle bone plate. Some studies showed that significant loss of tissue contour occurs during the first month after tooth extraction, averaging 3~5mm in width at 6 months. As a result, a residual ridge is often inadequate for ideal implant placement, which creating a clinical challenge for the placement of a dental implant in an ideal position. However, placement of a dental implant in an ideal three-dimensional position is critical in achieving a predictable functional and esthetic restoration.
Therefore, the timing of implant placement in extraction sockets can influence the surgery operability and treatment period of time. The classifications of timing of implant placement in extraction sockets as following: Type I: immediate implant placement: implant placement immediately following tooth extraction and as part of the same surgical procedure. Type II: early implant placement: surgery after complete soft tissue coverage of the socket (typically 4~8 weeks).Type III: early implant placement: implant surgery after substantial clinical and/or radiographic bone fill of the socket (typically 12~16 weeks). Type IV: late implant placement: surgery at healed site (typically more than 16 weeks). Considering of technique sensitivity and treatment time consuming, early implant placement is the most acceptable clinically. However, different treatment strategies may be applied because of the vary amounts of resorption after tooth extraction.
Some of the extraction sockets will heal completely and the implant can be placed in an ideal position 3 months after tooth extraction. Others may require adjunctive surgical procedures (like guided bone regeneration, GBR) during the implant surgery. In some cases, with severe bone resorption after tooth extraction, staged approach for implant placement is recommended due to lack of sufficient bone volume, which is the most time consuming and expensive treatment method.
In order to avoid this situation, some surgical procedures have been described to prevent alveolar ridge collapsing after tooth extraction, including regenerative techniques for socket preservation and immediate implant placement after tooth extraction. The socket preservation technique has been widely tested in controlled and uncontrolled studies with various materials and clinical approaches. However, this may require longer treatment period compare to early implant placement protocol and so far, there is no study revealed how often and when does socket preservation need to prevent the residual ridge deformity in our daily clinical practice.
Purpose:
The purpose of this study is to evaluate:
- How often do the clinical cases require ridge preservation than early implant placement protocol?
- Which factors may influence the clinical decision?
Hypothesis:
Ridge preservation is better than early implant placement protocol.
Importance:
Help the clinician to make a more precise decision-making.
- Conditions
- Dental Implants
- Being tested
- implant can be placed or not
- Keywords
- alveolar ridge preservation, Early implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant can be placed or notProcedure or surgery
the possibility of receiving dental implants
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patient who received an implant after surgery. Receives: Procedure: implant can be placed or not | |
| Group 2 | Patient who didn't receive an implant due to insufficient bone volume or implant primary stability for implant placement. Receives: Procedure: implant can be placed or not |
What is being measured
The primary outcome is the main question the study is designed to answer.
reason for tooth extraction
due to caries, periodontal disease, tooth fracture, residual root, endodontic failure
Measured: at the day of implant surgery
Secondary outcomes (1)
Radiographic analysis
with or without apical lesion and with or without marginal bone loss
Measured: at the day of implant surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start10 Apr 2014
- Primary completion3 Jan 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 133 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Chimei Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHUNJUNG CHEN, Chimei Medical Center
- Investigators
- CHUNJUNG CHEN, MS, Principal investigator, Chimei Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742151
- Sponsor's protocol ID
- 1 0 3 0 3 - 0 0 5
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahn JJ, Shin HI. Bone tissue formation in extraction sockets from sites with advanced periodontal disease: a histomorphometric study in humans. Int J Oral Maxillofac Implants. 2008 Nov-Dec;23(6):1133-8.
PubMed 19216285Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
PubMed 15691354Buser D, Chappuis V, Belser UC, Chen S. Implant placement post extraction in esthetic single tooth sites: when immediate, when early, when late? Periodontol 2000. 2017 Feb;73(1):84-102. doi: 10.1111/prd.12170.
PubMed 28000278Cardaropoli G, Araujo M, Hayacibara R, Sukekava F, Lindhe J. Healing of extraction sockets and surgically produced - augmented and non-augmented - defects in the alveolar ridge. An experimental study in the dog. J Clin Periodontol. 2005 May;32(5):435-40. doi: 10.1111/j.1600-051X.2005.00692.x.
PubMed 15842256Cardaropoli G, Araujo M, Lindhe J. Dynamics of bone tissue formation in tooth extraction sites. An experimental study in dogs. J Clin Periodontol. 2003 Sep;30(9):809-18. doi: 10.1034/j.1600-051x.2003.00366.x.
PubMed 12956657Hammerle CH, Araujo MG, Simion M; Osteology Consensus Group 2011. Evidence-based knowledge on the biology and treatment of extraction sockets. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:80-2. doi: 10.1111/j.1600-0501.2011.02370.x.
PubMed 22211307
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevalence Rate and Related Risk Factors of Ridge Preservation
- ClinicalTrials.gov ID
- NCT06742151
- Acronym / sponsor ID
- 1 0 3 0 3 - 0 0 5
- Conditions
- Dental Implants
- Keywords
- alveolar ridge preservation, Early implant placement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Chimei Medical CenterUniversity, hospital or other
- Study start
- 10 Apr 2014 (actual)
- Primary completion
- 3 Jan 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 19 Dec 2024 (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.
Treated by dental implant is a well document and popular therapy nowadays. Placement of a dental implant in an ideal three-dimensional position is critical in achieving a predictable long-term success. However, healing of an extraction socket involves bone remodeling, which inevitably leads to atrophic changes of the alveolar ridge. Studies have shown that most of the resorption occurs during the first 3 months of healing, although dimensional changes can be observed up to 1 year after tooth extraction, resulting in approximately 50% reduction of the bucco-lingual dimension of the alveolar ridge, mainly due to the resorption of the bundle bone plate.
Therefore, the timing of implant placement in extraction sockets can influence the surgery operability and treatment period of time. The classifications of timing of implant placement in extraction sockets as following: Type I: immediate implant placement: implant placement immediately following tooth extraction and as part of the same surgical procedure. Type II: early implant placement: surgery after complete soft tissue coverage of the socket (typically 4~8 weeks).
Type III: early implant placement: implant surgery after substantial clinical and/or radiographic bone fill of the socket (typically 12~16 weeks). Type IV: late implant placement: surgery at healed site (typically more than 16 weeks). Considering of technique sensitivity and treatment time consuming, early implant placement is the most acceptable clinically.
Many techniques have been developed to maintain the architecture of residual alveolar ridges and regenerative techniques for socket preservation is one of them. This procedure has been widely tested in controlled and uncontrolled studies with various materials and clinical approaches. However, this procedure may require longer treatment period compare to conventional or early implant placement protocol. Meanwhile, there is no study revealed how often and when does socket preservation need to prevent the residual ridge deformity in our daily clinical practice. The aim of the study is try to retrospectively find out the possible advantages and percentage of ridge preservation after tooth extraction in order to understand whether the socket preservation technique is necessary after tooth extraction, and the possible factors which might affect the clinical decision-making.
Detailed description
Background:
The alveolar process is a tooth-dependent tissue that develops in conjunction with the eruption of the teeth. The tooth is anchored to the jaws via the bundle bone into which the periodontal ligament fibers invest. Subsequent to the removal of the tooth, the alveolar process will undergo atrophy. The dynamics and magnitude of these changes have been investigated in the dog model as well as in humans. Most of the resorption occurs during the first 3 months of healing, although dimensional changes can be observed up to 1 year after tooth extraction, resulting in approximately 50% reduction of the bucco-lingual dimension of the alveolar ridge, mainly due to the resorption of the bundle bone plate. Some studies showed that significant loss of tissue contour occurs during the first month after tooth extraction, averaging 3~5mm in width at 6 months. As a result, a residual ridge is often inadequate for ideal implant placement, which creating a clinical challenge for the placement of a dental implant in an ideal position. However, placement of a dental implant in an ideal three-dimensional position is critical in achieving a predictable functional and esthetic restoration.
Therefore, the timing of implant placement in extraction sockets can influence the surgery operability and treatment period of time. The classifications of timing of implant placement in extraction sockets as following: Type I: immediate implant placement: implant placement immediately following tooth extraction and as part of the same surgical procedure. Type II: early implant placement: surgery after complete soft tissue coverage of the socket (typically 4~8 weeks).Type III: early implant placement: implant surgery after substantial clinical and/or radiographic bone fill of the socket (typically 12~16 weeks). Type IV: late implant placement: surgery at healed site (typically more than 16 weeks). Considering of technique sensitivity and treatment time consuming, early implant placement is the most acceptable clinically. However, different treatment strategies may be applied because of the vary amounts of resorption after tooth extraction.
Some of the extraction sockets will heal completely and the implant can be placed in an ideal position 3 months after tooth extraction. Others may require adjunctive surgical procedures (like guided bone regeneration, GBR) during the implant surgery. In some cases, with severe bone resorption after tooth extraction, staged approach for implant placement is recommended due to lack of sufficient bone volume, which is the most time consuming and expensive treatment method.
In order to avoid this situation, some surgical procedures have been described to prevent alveolar ridge collapsing after tooth extraction, including regenerative techniques for socket preservation and immediate implant placement after tooth extraction. The socket preservation technique has been widely tested in controlled and uncontrolled studies with various materials and clinical approaches. However, this may require longer treatment period compare to early implant placement protocol and so far, there is no study revealed how often and when does socket preservation need to prevent the residual ridge deformity in our daily clinical practice.
Purpose:
The purpose of this study is to evaluate:
- How often do the clinical cases require ridge preservation than early implant placement protocol?
- Which factors may influence the clinical decision?
Hypothesis:
Ridge preservation is better than early implant placement protocol.
Importance:
Help the clinician to make a more precise decision-making.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: implant can be placed or notPatient who received an implant after surgery. |
| Group 2 | – | Procedure: implant can be placed or notPatient who didn't receive an implant due to insufficient bone volume or implant primary stability for implant placement. |
Who may qualify
- Ages
- 21 to 81 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who plan to have single implant surgery from July 2009 to August 2015 were included in this study.
Key inclusion criteria (2 listed)
- periapical film at the time of tooth extraction
- implant surgery was scheduled within 4 months after tooth extraction.
Key exclusion criteria (1 listed)
- who cannot identify the reason for tooth extraction or unclear periapical film
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 |
|---|---|---|
| implant can be placed or notthe possibility of receiving dental implants | Procedure or surgery | Group 1, Group 2 |
Primary outcome
reason for tooth extraction
Time frame: at the day of implant surgery
due to caries, periodontal disease, tooth fracture, residual root, endodontic failure
1 secondary outcome
Radiographic analysis
Time frame: at the day of implant surgery
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 24 Dec 2024.
- Results publication: PubMed 19216285Ahn JJ, Shin HI. Bone tissue formation in extraction sockets from sites with advanced periodontal disease: a histomorphometric study in humans. Int J Oral Maxillofac Implants. 2008 Nov-Dec;23(6):1133-8.
- Results publication: PubMed 15691354Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
- Results publication: PubMed 28000278Buser D, Chappuis V, Belser UC, Chen S. Implant placement post extraction in esthetic single tooth sites: when immediate, when early, when late? Periodontol 2000. 2017 Feb;73(1):84-102. doi: 10.1111/prd.12170.
- Results publication: PubMed 15842256Cardaropoli G, Araujo M, Hayacibara R, Sukekava F, Lindhe J. Healing of extraction sockets and surgically produced - augmented and non-augmented - defects in the alveolar ridge. An experimental study in the dog. J Clin Periodontol. 2005 May;32(5):435-40. doi: 10.1111/j.1600-051X.2005.00692.x.
- Results publication: PubMed 12956657Cardaropoli G, Araujo M, Lindhe J. Dynamics of bone tissue formation in tooth extraction sites. An experimental study in dogs. J Clin Periodontol. 2003 Sep;30(9):809-18. doi: 10.1034/j.1600-051x.2003.00366.x.
- Results publication: PubMed 22211307Hammerle CH, Araujo MG, Simion M; Osteology Consensus Group 2011. Evidence-based knowledge on the biology and treatment of extraction sockets. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:80-2. doi: 10.1111/j.1600-0501.2011.02370.x.
- Individual participant dataSharing planned: No
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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.
CHUNJUNG CHEN, MS principal investigator
Chimei Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implants, run by Chimei Medical Center.
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 2 inclusion and 1 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 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
reason for tooth extraction (time frame: at the day of implant surgery). 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 NCT06742151, which also lists 6 linked publications.
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 24 Dec 2024.