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

The European Research Group on Periodontology (ERGOPerio)

Status: Completed

Conditions: Periodontitis Complex

Treatments: Procedure: Tooth extraction and replacement; Device: Enamel matrix derivative, bone replacement graft, barrier membrane

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04227964

ATRO1998

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Periodontal regeneration

Experimental group

Description:

Periodontal regeneration consisting of papilla preservation flaps, application of FDA approved CE marked periodontal regenerative devices, tooth splinting and root canal treatment as required.

Treatment:

Device: Enamel matrix derivative, bone replacement graft, barrier membrane

Extraction and tooth replacement

Active Comparator group

Description:

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.

Treatment:

Procedure: Tooth extraction and replacement