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

Not Applicable

Completed

• Conditions: Periodontitis Complex
• Interventions: Device: Enamel matrix derivative, bone replacement graft, barrier membrane; Procedure: Tooth extraction and replacement

• Registration Number: NCT04227964
• Lead Sponsor: The European Research Group on Periodontology (ERGOPerio)

Brief Summary

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

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 Timeline

• Study Start: 1998-06-01
• Primary Completion: 2014-12-31
• Study Completion: 2014-12-31
• Status Verified: 2020-01
• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-01-11
• Last Update Submitted: 2020-01-11
• Study First Posted: 2020-01-14
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Periodontal regeneration	Enamel matrix derivative, bone replacement graft, barrier membrane	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	Tooth extraction and 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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Clinical attachment level gain	10 years	Control outcome of periodontal regeneration
Probing pocket depth	10 years	Control outcome of periodontal regeneration

Trial Locations

Locations (1)

Faculty of Dentistry, The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong