search
Back to results

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

Primary Purpose

Periodontitis Complex

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Enamel matrix derivative, bone replacement graft, barrier membrane
Tooth extraction and replacement
Sponsored by
The European Research Group on Periodontology (ERGOPerio)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis Complex focused on measuring periodontitis, periodontal regeneration, tooth extraction, dental implant, fixed partial denture, survival analysis, Complication free survival, Recurrence analysis, Oral health related quality of life

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Faculty of Dentistry, The University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Periodontal regeneration

Extraction and tooth replacement

Arm 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.

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.

Outcomes

Primary Outcome Measures

Tooth or tooth replacement survival
Presence of functional and symptoms free tooth or tooth replacement
Occurrence and cost of management of recurrence
Recurrence analysis
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)

Secondary Outcome Measures

Clinical attachment level gain
Control outcome of periodontal regeneration
Probing pocket depth
Control outcome of periodontal regeneration

Full Information

First Posted
January 9, 2020
Last Updated
January 11, 2020
Sponsor
The European Research Group on Periodontology (ERGOPerio)
search

1. Study Identification

Unique Protocol Identification Number
NCT04227964
Brief Title
Periodontal Regeneration Versus Tooth Extraction and Replacement Denture in Teeth With Periodontal Hopeless Prognosis
Official Title
Periodontal Regeneration vs Extraction and Replacement of Teeth Severely Compromised by Attachment Loss to the Apex: a 10-year RCT
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 1998 (Actual)
Primary Completion Date
December 31, 2014 (Actual)
Study Completion Date
December 31, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The European Research Group on Periodontology (ERGOPerio)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis Complex
Keywords
periodontitis, periodontal regeneration, tooth extraction, dental implant, fixed partial denture, survival analysis, Complication free survival, Recurrence analysis, Oral health related quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single center RCT
Masking
Outcomes Assessor
Masking Description
Independent examiner
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Periodontal regeneration
Arm Type
Experimental
Arm 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.
Arm Title
Extraction and tooth replacement
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Enamel matrix derivative, bone replacement graft, barrier membrane
Intervention Type
Procedure
Intervention Name(s)
Tooth extraction and replacement
Primary Outcome Measure Information:
Title
Tooth or tooth replacement survival
Description
Presence of functional and symptoms free tooth or tooth replacement
Time Frame
10 year
Title
Occurrence and cost of management of recurrence
Description
Recurrence analysis
Time Frame
10-year
Title
Oral health related quality of life: OHIP-14 (Oral Health Impact Profile)
Description
14 validated questions, 5 point Liker scale, smaller scores represent better outcome (smaller impact on quality of life)
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Clinical attachment level gain
Description
Control outcome of periodontal regeneration
Time Frame
10 years
Title
Probing pocket depth
Description
Control outcome of periodontal regeneration
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierpaolo Cortellini, MD
Organizational Affiliation
Investigator
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry, The University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32249446
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs