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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04227964
Recruitment Status : Completed
First Posted : January 14, 2020
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
The European Research Group on Periodontology (ERGOPerio)

Tracking Information
First Submitted Date  ICMJE January 9, 2020
First Posted Date  ICMJE January 14, 2020
Last Update Posted Date January 14, 2020
Actual Study Start Date  ICMJE June 1, 1998
Actual Primary Completion Date December 31, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2020)
  • Tooth or tooth replacement survival [ Time Frame: 10 year ]
    Presence of functional and symptoms free tooth or tooth replacement
  • Occurrence and cost of management of recurrence [ Time Frame: 10-year ]
    Recurrence analysis
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2020)
  • Clinical attachment level gain [ Time Frame: 10 years ]
    Control outcome of periodontal regeneration
  • Probing pocket depth [ Time Frame: 10 years ]
    Control outcome of periodontal regeneration
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Periodontal Regeneration Versus Tooth Extraction and Replacement Denture in Teeth With Periodontal Hopeless Prognosis
Official Title  ICMJE Periodontal Regeneration vs Extraction and Replacement of Teeth Severely Compromised by Attachment Loss to the Apex: a 10-year RCT
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Single center RCT
Masking: Single (Outcomes Assessor)
Masking Description:
Independent examiner
Primary Purpose: Treatment
Condition  ICMJE Periodontitis Complex
Intervention  ICMJE
  • Device: Enamel matrix derivative, bone replacement graft, barrier membrane
  • Procedure: Tooth extraction and replacement
Study Arms  ICMJE
  • 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.
    Intervention: Device: Enamel matrix derivative, bone replacement graft, barrier membrane
  • 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.
    Intervention: Procedure: Tooth extraction and replacement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2020)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2014
Actual Primary Completion Date December 31, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04227964
Other Study ID Numbers  ICMJE ATRO1998
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The European Research Group on Periodontology (ERGOPerio)
Study Sponsor  ICMJE The European Research Group on Periodontology (ERGOPerio)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pierpaolo Cortellini, MD Investigator
PRS Account The European Research Group on Periodontology (ERGOPerio)
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP