NCT04227964

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 1998

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1998

Completed
16.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2014

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

16.6 years

First QC Date

January 9, 2020

Last Update Submit

January 11, 2020

Conditions

Periodontitis Complex

Keywords

periodontitisperiodontal regenerationtooth extractiondental implantfixed partial denturesurvival analysisComplication free survivalRecurrence analysisOral health related quality of life

Outcome Measures

Primary Outcomes (3)

  • Tooth or tooth replacement survival

    Presence of functional and symptoms free tooth or tooth replacement

    10 year

  • Occurrence and cost of management of recurrence

    Recurrence analysis

    10-year

  • 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)

    10 years

Secondary Outcomes (2)

  • Clinical attachment level gain

    10 years

  • Probing pocket depth

    10 years

Study Arms (2)

Periodontal regeneration

EXPERIMENTAL

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

Extraction and tooth replacement

ACTIVE COMPARATOR

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

Interventions

Enamel matrix derivative, bone replacement graft, barrier membraneDEVICE
Periodontal regeneration
Tooth extraction and replacementPROCEDURE
Extraction and tooth replacement

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Medical contraindication to elective surgery
  • Poor oral hygiene
  • Incomplete control of periodontitis in the dentition
  • Inadequate compliance
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

  • 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.

    PMID: 32249446DERIVED

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth ExtractionReplantation

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeDentistryTransplantation

Study Officials

  • Pierpaolo Cortellini, MD

    Investigator

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Independent examiner
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single center RCT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2020

First Posted

January 14, 2020

Study Start

June 1, 1998

Primary Completion

December 31, 2014

Study Completion

December 31, 2014

Last Updated

January 14, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)