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

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hong Kong, Hong Kong
        • Faculty of Dentistry, The University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Periodontal regeneration
Periodontal regeneration consisting of papilla preservation flaps, application of FDA approved CE marked periodontal regenerative devices, tooth splinting and root canal treatment as required.
Active Comparator: Extraction and tooth 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tooth or tooth replacement survival
Time Frame: 10 year
Presence of functional and symptoms free tooth or tooth replacement
10 year
Occurrence and cost of management of recurrence
Time Frame: 10-year
Recurrence analysis
10-year
Oral health related quality of life: OHIP-14 (Oral Health Impact Profile)
Time Frame: 10 years
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
Time Frame: 10 years
Control outcome of periodontal regeneration
10 years
Probing pocket depth
Time Frame: 10 years
Control outcome of periodontal regeneration
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Pierpaolo Cortellini, MD, Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 1998

Primary Completion (Actual)

December 31, 2014

Study Completion (Actual)

December 31, 2014

Study Registration Dates

First Submitted

January 9, 2020

First Submitted That Met QC Criteria

January 11, 2020

First Posted (Actual)

January 14, 2020

Study Record Updates

Last Update Posted (Actual)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 11, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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