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Completed

NCT Number: NCT04227964

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

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.

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Key information

Conditions

Periodontitis Complex Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, The University of Hong Kong

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enamel matrix derivative, bone replacement graft, barrier membrane

Device

Tooth extraction and replacement

Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The European Research Group on Periodontology (ERGOPerio)

Network

Registry information

Official study title

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

Important dates

Study start
1998
Primary completion
2014
Study completion
2014
First posted
Jan 14, 2020
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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