This trial is active, not recruiting.

Condition chronic periodontitis
Treatments non-surgical subgingival debridement (sd), simplified papilla preservation flap, resective periodontal flap with osseous recontouring (rpfo)
Phase phase 3
Sponsor University College, London
Collaborator Eastman Dental Insitute and Hospital
Start date January 2013
End date December 2018
Trial size 48 participants
Trial identifier NCT01642641, 12/0332, P-07-34


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
(Active Comparator)
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
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 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.

Primary Outcomes

Change from Baseline in Periodontal Probing Depths (PPD)
time frame: 3, 6 and 12 months
Change from Baseline of EuroQol-5D-3L and Condition Specific Oral Impacts on Daily Performance Questionnaire
time frame: 3, 6, 9 and 12 months

Secondary Outcomes

Incremental cost per quality-adjusted life year gained
time frame: 3, 6, 9 and 12 months
Clinical attachment level (CAL) change
time frame: 3, 6 and 12 months
Radiographic bone change
time frame: 12 months
Change in subgingival microbiota
time frame: 3, 6 and 12 months

Eligibility Criteria

Male or female participants at least 30 years old.

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 one interdental areas with a pockets ≥6mm (PPD), bleeding on probing (BOP), and attachment loss ≥6mm in any posterior sextants of their mouth (exluding third molars and distal of second molars) OR have multiple sites (≥ 9) with PPD ≥ 5mm and attachment loss ≥ 5mm . 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.

Additional Information

Official title The Efficacy of Different Surgical Modalities in the Treatment of Periodontitis. A Single-Centre Randomised Controlled Trial
Principal investigator Nikolaos Donos, DDS, MS, PhD
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University College, London.