Different Surgical Modalities in the Treatment of Periodontitis
|Chronic Periodontitis||Procedure: Non-surgical Subgingival Debridement (SD) Procedure: Simplified Papilla Preservation Flap Procedure: Resective Periodontal Flap with Osseous Recontouring (RPFO)||Phase 3|
|Study Design:||Allocation: Randomized
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|
- Change from Baseline in Periodontal Probing Depths (PPD) [ Time Frame: 3, 6 and 12 months ]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 ]To assess impact on quality of life.
- Incremental cost per quality-adjusted life year gained [ Time Frame: 3, 6, 9 and 12 months ]To determine cost-effectiveness from an NHS perspective
- Clinical attachment level (CAL) change [ Time Frame: 3, 6 and 12 months ]
- Radiographic bone change [ Time Frame: 12 months ]As determined from standardized peri-apical radiographs
- Change in subgingival microbiota [ Time Frame: 3, 6 and 12 months ]Assessed via pooled samples and analyzed via Q-PCR
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
|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.
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 87 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01642641
|Eastman Clinical Investigation Centre|
|London, United Kingdom, WC1X 8LD|
|Principal Investigator:||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|
|Study Chair:||Natalie M Leow, BDS, MDSc||UCL Eastman Dental Institute|