- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06742151
Evaluation of the Prevalence Rate and Related Risk Factors of Ridge Preservation
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- periapical film at the time of tooth extraction
- implant surgery was scheduled within 4 months after tooth extraction.
Exclusion Criteria:
- who cannot identify the reason for tooth extraction or unclear periapical film
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1
Patient who received an implant after surgery.
|
the possibility of receiving dental implants
|
|
Group 2
Patient who didn't receive an implant due to insufficient bone volume or implant primary stability for implant placement.
|
the possibility of receiving dental implants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
reason for tooth extraction
Time Frame: at the day of implant surgery
|
due to caries, periodontal disease, tooth fracture, residual root, endodontic failure
|
at the day of implant surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Radiographic analysis
Time Frame: at the day of implant surgery
|
with or without apical lesion and with or without marginal bone loss
|
at the day of implant surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: CHUNJUNG CHEN, MS, ChiMei Medical Center
Publications and helpful links
General Publications
- Hammerle 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. Erratum In: Clin Oral Implants Res. 2012 May;23(5):641.
- Araujo 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.
- Cardaropoli 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.
- Cardaropoli 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.
- Buser 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1 0 3 0 3 - 0 0 5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dental Implants
-
Alexandria UniversityActive, not recruitingDental Implants | Dental Implants, Single-toothEgypt
-
Universiti Sains MalaysiaActive, not recruitingDental Implantation | Dental ImplantsChina
-
University of ChileCompletedDental Implants | Maxillary Alveolar Reconstruction | Dental Implants , Osseointegration , Marginal Bone Loss , Implant StabilityChile
-
Mohammed Bin Rashid University of Medicine and...RecruitingDental ImplantsUnited Arab Emirates
-
Daniele MorettoNot yet recruitingDental Implants
-
Shanghai Ninth People's Hospital Affiliated to...Recruiting
-
Global DRecruitingDental ImplantsFrance, Greece
-
Cairo UniversityActive, not recruiting
-
Aula Dental AvanzadaActive, not recruiting
Clinical Trials on implant can be placed or not
-
Odense University HospitalCompletedUnconscious (Psychology)Denmark
-
Zhejiang Cancer HospitalRecruitingMetastatic Breast Cancer in the LiverChina
-
Boston Scientific CorporationGuidant CorporationCompletedVentricular Fibrillation | Ventricular TachycardiaGermany, Spain, Canada, Israel, Netherlands, France, Finland, United Kingdom, Austria, Malaysia, Thailand, Hong Kong, Sweden, Hungary, Australia, Czechia, Norway, Poland
-
Cardioangiologisches Centrum BethanienWithdrawnUrgent Surgery | Severe Bleeding
-
West China HospitalNot yet recruiting
-
University Hospital, GhentCompletedUncomplicated Acute CholecystitisBelgium, Qatar
-
Mansoura UniversityActive, not recruitingSoft Tissue AtrophyEgypt
-
UMC UtrechtCompleted
-
New York Institute of TechnologyRecruitingHead Injury TraumaUnited States
-
Memorial Sloan Kettering Cancer CenterNational Institutes of Health (NIH)Completed