Different Surgical Modalities in the Treatment of Periodontitis

NCT01642641 | Completed

• 2 other identifiers: 011467COCR0003
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of the present study is to determine: 1) the efficacy of 2 periodontal surgical procedures, the conservative simplified papilla preservation technique and the more resective open flap debridement with osseous recontouring, in the treatment of chronic periodontitis in terms of clinical, radiographic, microbiological, immunological and PROMs, comparing them to non-surgical subgingival debridement and 2) if possible, determine the surgical procedure which leads to pocket elimination or to the lowest number of residual pockets.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (2)

• Clinical efficacy of 3 different periodontal treatment approaches

  A clinical measure of resolution of disease from baseline in Periodontal Probing Depths (PPD)

  3, 6 and 12 months

• Change from Baseline of EuroQol-5D-5L and Condition Specific Oral Impacts on Daily Performance Questionnaire

  To assess impact on quality of life.

  Baseline, 1 week post-op, 3, 6, 9 and 12 months

Secondary Outcomes (9)

• To investigate the efficacy of 3 different periodontal treatment approaches on PROMs related to general health over a follow-up period of 12 months

  Treatment Visit 1, 3, 6 and 9 months

• Incremental cost per quality-adjusted life year gained

  3, 6, 9 and 12 months

• Maintenance/support needs of patients following treatment

  3, 6 and 12 months

• Radiographic bone changes of 3 different periodontal treatment approaches

  Baseline and 12 months

• Changes in subgingival microbiota

  Baseline, 3, 6 and 12 months

Study Arms (3)

Non-surgical subgingival debridement

ACTIVE COMPARATOR

Procedure: Non-surgical Subgingival Debridement (SD)

Simplified Papilla Preservation Flap

ACTIVE COMPARATOR

Procedure: Simplified Papilla Preservation Flap

Resective Flap with Osseous Recontouring

ACTIVE COMPARATOR

Procedure: Resective Periodontal Flap with Osseous Recontouring (RPFO)

Interventions

Non-surgical Subgingival Debridement (SD) PROCEDURE

SD is a conservative non-surgical procedure aimed at reducing dental plaque and calculus from the tooth root usually under local anaesthesia.

Non-surgical subgingival debridement

Simplified Papilla Preservation Flap PROCEDURE

The simplified papilla preservation flap is a novel conservative surgical procedure aimed at the preservation of the tissues between the teeth. It has been shown to significantly reduce pocket depth and has faster re-vascularisation of the flap, when compared with other procedures.

Simplified Papilla Preservation Flap

Resective Periodontal Flap with Osseous Recontouring (RPFO) PROCEDURE

RPFO is a surgical procedure that involves the resection of soft and hard tissue to obtain optimum tissue architecture and pocket reduction or elimination.

Resective Flap with Osseous Recontouring

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy males and females ≥ 30 years of age.
• Volunteers must be willing to read, and sign a copy of the Informed Consent Form after reading the Patient Information Leaflet and after the nature of the study has been fully explained.
• Present with clinical evidence of periodontitis, with one interdental area of PPD ≥6mm, BOP, and attachment loss ≥6mm in any posterior sextant of their mouth (excluding third molars and distal of second molars), or multiple sites (≥9) with PPD ≥5mm, BOP, and attachment loss ≥5mm.
• Have completed a course of non-surgical periodontal therapy within 2 years prior to study commencement and have had maintenance subgingival debridement within 6 months prior to assessment for eligibility.

You may not qualify if:

• Medical history that includes diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases e.g. cardiovascular disease or AIDS.
• History of rheumatic fever, heart murmur, mitral valve prolapse, artificial heart valve or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
• Antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam.
• History of alcohol or drug abuse.
• Self reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results).
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (3)

Barts Health NHS Trust Dental Hospital

London, E1 1BB, United Kingdom

Location

Centre for Oral Clinical Research

London, E1 2AD, United Kingdom

Location

Eastman Clinical Investigation Centre

London, WC1X 8LD, United Kingdom

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nikolaos Donos, DDS, MS, PhD

  Barts & The London School of Medicine & Dentistry, QMUL

  STUDY DIRECTOR

• Nikolaos Mardas, DDS, MS, PhD

  Barts & The London School of Medicine & Dentistry, QMUL

  PRINCIPAL INVESTIGATOR

• Natalie M Leow, BDS, MDSc

  UCL Eastman Dental Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2012
• First Posted: July 17, 2012
• Study Start: October 30, 2016
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

GB (3)