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

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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)

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.

Condition or disease Intervention/treatment Phase
Periodontitis Complex Device: Enamel matrix derivative, bone replacement graft, barrier membrane Procedure: Tooth extraction and replacement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single center RCT
Masking: Single (Outcomes Assessor)
Masking Description: Independent examiner
Primary Purpose: Treatment
Official Title: Periodontal Regeneration vs Extraction and Replacement of Teeth Severely Compromised by Attachment Loss to the Apex: a 10-year RCT
Actual Study Start Date : June 1, 1998
Actual Primary Completion Date : December 31, 2014
Actual Study Completion Date : December 31, 2014

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.
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.
Procedure: Tooth extraction and replacement



Primary Outcome Measures :
  1. Tooth or tooth replacement survival [ Time Frame: 10 year ]
    Presence of functional and symptoms free tooth or tooth replacement

  2. Occurrence and cost of management of recurrence [ Time Frame: 10-year ]
    Recurrence analysis

  3. 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)


Secondary Outcome Measures :
  1. Clinical attachment level gain [ Time Frame: 10 years ]
    Control outcome of periodontal regeneration

  2. Probing pocket depth [ Time Frame: 10 years ]
    Control outcome of periodontal regeneration



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04227964


Locations
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Hong Kong
Faculty of Dentistry, The University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
The European Research Group on Periodontology (ERGOPerio)
Investigators
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Study Director: Pierpaolo Cortellini, MD Investigator

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Responsible Party: The European Research Group on Periodontology (ERGOPerio)
ClinicalTrials.gov Identifier: NCT04227964    
Other Study ID Numbers: ATRO1998
First Posted: January 14, 2020    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The European Research Group on Periodontology (ERGOPerio):
periodontitis
periodontal regeneration
tooth extraction
dental implant
fixed partial denture
survival analysis
Complication free survival
Recurrence analysis
Oral health related quality of life
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases