Clinical trial NCT04227964: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: The European Research Group on Periodontology (ERGOPerio)
Sponsor class: NETWORK
First posted: 2020-01-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center RCT
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Tooth or tooth replacement survival
timeFrame: 10 year
measure: Occurrence and cost of management of recurrence
timeFrame: 10-year
measure: Oral health related quality of life: OHIP-14 (Oral Health Impact Profile)
timeFrame: 10 years
Secondary outcomes:
measure: Clinical attachment level gain
timeFrame: 10 years
measure: Probing pocket depth
timeFrame: 10 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Faculty of Dentistry, The University of Hong Kong
Study officials:
affiliation: Investigator
name: Pierpaolo Cortellini, MD
role: STUDY_DIRECTOR
References:
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.