Periodontal Regeneration Versus Tooth Extraction and Replacement Denture in Teeth With Periodontal Hopeless Prognosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Periodontal Regeneration vs Extraction and Replacement of Teeth Severely Compromised by Attachment Loss to the Apex: a 10-year RCT

Conditions
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Periodontitis Complex

Intervention / Treatment
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* Device: Enamel matrix derivative, bone replacement graft, barrier membrane
* Procedure: Tooth extraction and replacement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single center RCT
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Periodontal regeneration<br>Periodontal regeneration consisting of papilla preservation flaps, application of FDA approved CE marked periodontal regenerative devices, tooth splinting and root canal treatment as required. | Device: Enamel matrix derivative, bone replacement graft, barrier membrane<br> <br> |
| Active Comparator: Extraction and tooth replacement<br>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. | Procedure: Tooth extraction and replacement<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tooth or tooth replacement survival | Presence of functional and symptoms free tooth or tooth replacement | 10 year | 
| Occurrence and cost of management of recurrence | Recurrence analysis | 10-year | 
| Oral health related quality of life: OHIP-14 (Oral Health Impact Profile) | 14 validated questions, 5 point Liker scale, smaller scores represent better outcome (smaller impact on quality of life) | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical attachment level gain | Control outcome of periodontal regeneration | 10 years | 
| Probing pocket depth | Control outcome of periodontal regeneration | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periodontitis, periodontal regeneration, tooth extraction, dental implant, fixed partial denture, survival analysis, Complication free survival, Recurrence analysis, Oral health related quality of life