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CompletedNCT06742151Updated Dec 24, 2024

Evaluation of the Prevalence Rate and Related Risk Factors of Ridge Preservation

An observational study in Dental Implants, sponsored by Chimei Medical Center. Completed. Open to participants aged 21 Years to 81 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-24.

Sponsored by Chimei Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
133
Ages
21 Years to 81 Years
Sex
All
01

Study 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. 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.

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:

  1. How often do the clinical cases require ridge preservation than early implant placement protocol?
  2. 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.

02

Conditions studied

  • Dental Implants

Keywords

  • alveolar ridge preservation
  • Early implant placement
03

In context

Lead sponsor

Chimei Medical Center is the lead sponsor of 27 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 81 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients who plan to have single implant surgery from July 2009 to August 2015 were included in this study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • periapical film at the time of tooth extraction
  • implant surgery was scheduled within 4 months after tooth extraction.

Exclusion criteria

Exclusion Criteria:

- who cannot identify the reason for tooth extraction or unclear periapical film

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
133 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Group 1

    Patient who received an implant after surgery.

    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.

    Procedure: implant can be placed or not

Interventions

  • Procedureimplant can be placed or not

    the possibility of receiving dental implants

06

What researchers measure

Primary outcomes

  1. reason for tooth extraction

    due to caries, periodontal disease, tooth fracture, residual root, endodontic failure

    Time frame: at the day of implant surgery

Secondary outcomes

  1. Radiographic analysis

    with or without apical lesion and with or without marginal bone loss

    Time frame: at the day of implant surgery

07

Study locations

No study locations are listed for this record.

08

References and documents

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 19216285 ↗
  • 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. PubMed 15691354 ↗
  • 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. PubMed 28000278 ↗
  • 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. PubMed 15842256 ↗
  • 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. PubMed 12956657 ↗
  • 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. PubMed 22211307 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2014 to primary completion in Jan 2018, 44 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 16, 2024
First posted
Dec 19, 2024
StartActual
Apr 10, 2014
Primary completionActual
Jan 3, 2018
CompletionActual
Mar 31, 2019
Last update
Dec 24, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06742151
Lead sponsor
Chimei Medical Center
Responsible party
CHUNJUNG CHEN (Director of Periodontics, Chimei Medical Center) — Principal investigator
First posted
Dec 19, 2024
Start date
Apr 10, 2014
Primary completion
Jan 3, 2018
Completion
Mar 31, 2019
Last update
Dec 24, 2024

Study contacts

CHUNJUNG CHEN, MS
principal investigator · Chimei Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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