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

Periodontitis Complex Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04227964
• Other study ID #: ATRO1998
• Status: Completed
• Phase: N/A
• Start date: June 1, 1998
• Est. completion date: December 31, 2014

Study information

• Verified date: January 2020
• Source: The European Research Group on Periodontology (ERGOPerio)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2014
• Est. primary completion date: December 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis
• Periodontitis Complex

Intervention

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

Procedure:
• Tooth extraction and replacement

Locations

Country	Name	City	State
Hong Kong	Faculty of Dentistry, The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The European Research Group on Periodontology (ERGOPerio)

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tooth or tooth replacement survival	Presence of functional and symptoms free tooth or tooth replacement	10 year
Primary	Occurrence and cost of management of recurrence	Recurrence analysis	10-year
Primary	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	Clinical attachment level gain	Control outcome of periodontal regeneration	10 years
Secondary	Probing pocket depth	Control outcome of periodontal regeneration	10 years