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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04227964

Enrollment

Registered

2020-01-14

Start date

1998-06-01

Completion date

2014-12-31

Last updated

2020-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DEVICEEnamel matrix derivative, bone replacement graft, barrier membrane

PROCEDURETooth extraction and replacement

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Masking description

Independent examiner

Intervention model description

Single center RCT

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Tooth or tooth replacement survival	10 year	Presence of functional and symptoms free tooth or tooth replacement
Occurrence and cost of management of recurrence	10-year	Recurrence analysis
Oral health related quality of life: OHIP-14 (Oral Health Impact Profile)	10 years	14 validated questions, 5 point Liker scale, smaller scores represent better outcome (smaller impact on quality of life)

Secondary

Measure	Time frame	Description
Clinical attachment level gain	10 years	Control outcome of periodontal regeneration
Probing pocket depth	10 years	Control outcome of periodontal regeneration

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026