Different Surgical Modalities in the Treatment of Periodontitis

This study is currently recruiting participants.
Verified December 2013 by University College, London
Sponsor:
Collaborator:
Eastman Dental Insitute and Hospital
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01642641
First received: July 11, 2012
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to determine the most efficient treatment approach (two surgical and one non-surgical) in the treatment of moderate to severe chronic periodontitis, with regard to healing and resolution of disease, patient reported outcomes and cost effectiveness.


Condition Intervention Phase
Chronic Periodontitis
Procedure: Non-surgical Subgingival Debridement (SD)
Procedure: Simplified Papilla Preservation Flap
Procedure: Resective Periodontal Flap with Osseous Recontouring (RPFO)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Different Surgical Modalities in the Treatment of Periodontitis. A Single-Centre Randomised Controlled Trial

Further study details as provided by University College, London:

Primary Outcome Measures:
  • Change from Baseline in Periodontal Probing Depths (PPD) [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
    A clinical measure of resolution of disease

  • Change from Baseline of EuroQol-5D-3L and Condition Specific Oral Impacts on Daily Performance Questionnaire [ Time Frame: 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
    To assess impact on quality of life.


Secondary Outcome Measures:
  • Incremental cost per quality-adjusted life year gained [ Time Frame: 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
    To determine cost-effectiveness from an NHS perspective

  • Clinical attachment level (CAL) change [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Radiographic bone change [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    As determined from standardized peri-apical radiographs

  • Change in subgingival microbiota [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
    Assessed via pooled samples and analyzed via Q-PCR


Estimated Enrollment: 117
Study Start Date: January 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Non-surgical subgingival debridement Procedure: Non-surgical Subgingival Debridement (SD)
SD is a conservative non-surgical procedure aimed at reducing dental plaque and calculus from the tooth root usually under local anaesthesia.
Active Comparator: Simplified Papilla Preservation Flap Procedure: Simplified Papilla Preservation Flap
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.
Active Comparator: Resective Flap with Osseous Recontouring Procedure: Resective Periodontal Flap with Osseous Recontouring (RPFO)
RPFO is a surgical procedure that involves the resection of soft and hard tissue to obtain optimum tissue architecture and pocket reduction or elimination.

Detailed Description:

Periodontal diseases (PD) are highly prevalent chronic diseases, and may be associated with loss of gum and bone tissue surrounding the tooth. Among adults (with 2 or more teeth remaining) in England, 54% experienced gum bleeding and 45% had periodontal (gum) disease of which 9% was severe. Bacterial in origin, the high prevalence of PD, together with increased retention of teeth at older ages, has considerable implications for the population's future treatment needs and the associated costs to the health system. It is therefore important to ensure interventions delivered are those proven to be most efficient and cost effective. The investigators study question will therefore be, "In an adult population with moderate to severe chronic periodontitis, how will 3 different treatment approaches; simplified papilla preservation flap (SPPF), resective periodontal flap with osseous recontouring (RPFO) and subgingival debridement (SD), differ in regard to healing and resolution of disease, patient reported outcomes and cost effectiveness?" The aim of this study is to find the most efficient way to treat chronic periodontitis, through a randomised controlled trial of 3 established forms of treatment.

Research will be carried out at the Eastman Dental Institute and Hospital, specifically in the Eastman Clinical Investigation Centre (ECIC), a dedicated clinical research centre. A total of 117 participants will be recruited in order to provide the necessary power to discriminate between the 3 treatment approaches. Eligible patients, who fit the inclusion criteria, will be drawn from hospital referrals and once informed consent is gained, will be randomised to one of the 3 approaches. Two surgical approaches (SPPF, RPFO) will be compared with a non-surgical (SD) approach, and followed up over a 12 month period. Among other things, the investigators will compare clinical parameters of wound healing (including bacterial changes), patient's quality of life and cost-effectiveness.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Systemically healthy males and females ≥ 30 years of age.
  2. Non-smokers or smokers .
  3. 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.
  4. Present at least two interdental areas with pockets ≥6mm (PPD), bleeding on probing (BOP), and attachment loss ≥6mm in at least 2 posterior sextants of their mouth.
  5. 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.

Exclusion Criteria:

  1. Medical history that includes uncontrolled diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases, e.g. cardiovascular disease or AIDS.
  2. History of rheumatic fever, heart murmur, mitral valve prolapse, artificial heart valve or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
  3. Antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam.
  4. History of alcohol or drug abuse.
  5. 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).
  6. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01642641

Contacts
Contact: Nikolaos Donos, DDS, MS, PhD +44(0)2034561075 n.donos@ucl.ac.uk
Contact: Natalie Leow, BDS, MDSc +44(0)2034561171 n.leow@ucl.ac.uk

Locations
United Kingdom
Eastman Clinical Investigation Centre Recruiting
London, United Kingdom, WC1X 8LD
Contact: Natalie M Leow, BDS, MDSc    +44(0)2034561171    n.leow@ucl.ac.uk   
Principal Investigator: Nikolaos Donos, DDS, MS, PhD         
Principal Investigator: Nikolaos Mardas, DDS, MS, PhD         
Principal Investigator: Natalie M Leow, BDS, MDSc         
Sub-Investigator: Ian Needleman, BDS,MSc,PhD         
Sub-Investigator: Nikolaos Gkranias, DDS,MClinDen         
Sub-Investigator: Aviva Petrie, BSc,MSc,CSta         
Sub-Investigator: Georgios Tsakos, Dip,MSc,PhD         
Sub-Investigator: Jeanie Suvan, DipDH,MSc         
Sub-Investigator: Stephen Morris, MSc, PhD         
Sub-Investigator: Martin Utley, BSc,PhD         
Sub-Investigator: Francesco D'Aiuto, DMD,PhD         
Sub-Investigator: Xanthippi Dereka, DDS, PhD         
Sub-Investigator: David Spratt, PhD         
Sub-Investigator: Roberto Rotundo, DDS         
Sub-Investigator: Ulpee Darbar, BDS, MSc         
Sponsors and Collaborators
University College, London
Eastman Dental Insitute and Hospital
Investigators
Principal Investigator: Nikolaos Donos, DDS, MS, PhD UCL Eastman Dental Institute
Study Director: Nikolaos Mardas, DDS, MS, PhD UCL Eastman Dental Institute
Study Chair: Natalie M Leow, BDS, MDSc UCL Eastman Dental Institute
  More Information

No publications provided

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01642641     History of Changes
Other Study ID Numbers: P-07-34
Study First Received: July 11, 2012
Last Updated: December 12, 2013
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on April 17, 2014