- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04227964
Periodontal Regeneration Versus Tooth Extraction and Replacement Denture in Teeth With Periodontal Hopeless Prognosis
January 11, 2020 updated by: The European Research Group on Periodontology (ERGOPerio)
Periodontal Regeneration vs Extraction and Replacement of Teeth Severely Compromised by Attachment Loss to the Apex: a 10-year RCT
Periodontal regeneration can change tooth prognosis and represents an alternative to extraction in teeth compromised by severe intrabony defects.
The aim of this study is to compare periodontal regeneration (PR) with tooth extraction and replacement (TER) in a population with attachment loss to or beyond the apex of the root in terms of professional, patient reported and economic outcomes.
Study Overview
Status
Completed
Conditions
Detailed Description
This was a single center 10-year randomized controlled clinical trial.
50 stage III or IV periodontitis subjects with a severely compromised tooth with attachment loss to or beyond the apex were randomized to PR or TER with either an implant or a tooth supported fixed partial denture.
Subjects were kept on a strict periodontal supportive care regimen every 3 months and examined yearly.
Survival, complication free survival, recurrence analysis, oral health related quality of life and patient reported outcomes analyses will be performed.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Hong Kong, Hong Kong
- Faculty of Dentistry, The University of Hong Kong
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Good general health
- Non-smokers or smokers with less than 20/day
- Good oral hygiene (FMPS<25%)
- Good control of periodontitis (FMBS<25%)
- Good compliance with treatment
- Presence of generalised stage III or IV periodontitis
- Radiographic bone loss to the apex or beyond the apex of the root at at least one interdental aspect
- Presence of severe clinical attachment level loss (>10 mm)
- Presence of clearly identifiable crest of bone in adjacent teeth
- Lack of function due to hyper mobility
- Vital or non-vital teeth
Exclusion Criteria:
- Medical contraindication to elective surgery
- Poor oral hygiene
- Incomplete control of periodontitis in the dentition
- Inadequate compliance
- Inability to provide informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Periodontal regeneration
Periodontal regeneration consisting of papilla preservation flaps, application of FDA approved CE marked periodontal regenerative devices, tooth splinting and root canal treatment as required.
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Active Comparator: Extraction and tooth replacement
Tooth extraction and replacement with a dental implant or a fixed partial denture following healing and reconstruction of the extraction area.
Choice based on standard of practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tooth or tooth replacement survival
Time Frame: 10 year
|
Presence of functional and symptoms free tooth or tooth replacement
|
10 year
|
Occurrence and cost of management of recurrence
Time Frame: 10-year
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Recurrence analysis
|
10-year
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Oral health related quality of life: OHIP-14 (Oral Health Impact Profile)
Time Frame: 10 years
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14 validated questions, 5 point Liker scale, smaller scores represent better outcome (smaller impact on quality of life)
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10 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical attachment level gain
Time Frame: 10 years
|
Control outcome of periodontal regeneration
|
10 years
|
Probing pocket depth
Time Frame: 10 years
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Control outcome of periodontal regeneration
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Pierpaolo Cortellini, MD, Investigator
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 1998
Primary Completion (Actual)
December 31, 2014
Study Completion (Actual)
December 31, 2014
Study Registration Dates
First Submitted
January 9, 2020
First Submitted That Met QC Criteria
January 11, 2020
First Posted (Actual)
January 14, 2020
Study Record Updates
Last Update Posted (Actual)
January 14, 2020
Last Update Submitted That Met QC Criteria
January 11, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATRO1998
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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