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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Periodontal regeneration | Experimental | Periodontal regeneration consisting of papilla preservation flaps, application of FDA approved CE marked periodontal regenerative devices, tooth splinting and root canal treatment as required. |
|
| Extraction and tooth replacement | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enamel matrix derivative, bone replacement graft, barrier membrane | Device |
| ||
| Tooth extraction and replacement |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical attachment level gain | Control outcome of periodontal regeneration | 10 years |
| Probing pocket depth | Control outcome of periodontal regeneration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierpaolo Cortellini, MD | Investigator | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, The University of Hong Kong | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32249446 | Derived | Cortellini P, Stalpers G, Mollo A, Tonetti MS. Periodontal regeneration versus extraction and dental implant or prosthetic replacement of teeth severely compromised by attachment loss to the apex: A randomized controlled clinical trial reporting 10-year outcomes, survival analysis and mean cumulative cost of recurrence. J Clin Periodontol. 2020 Jun;47(6):768-776. doi: 10.1111/jcpe.13289. Epub 2020 Apr 19. |
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Single center RCT
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Independent examiner
| Procedure |
|
| 10 years |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014081 | Tooth Extraction |
| D012092 | Replantation |
| ID | Term |
|---|---|
| D019647 | Oral Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D003813 | Dentistry |
| D014180 | Transplantation |
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