- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01642641
Different Surgical Modalities in the Treatment of Periodontitis
The Efficacy of Different Surgical Modalities in the Treatment of Periodontitis. A Randomised Controlled Trial
Study Overview
Status
Conditions
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 multi-centre randomised, single-blind, parallel- surgical modalities groups (3 groups) clinical trial including 3 sites:: 1. QMUL Institute of Dentistry, Centre for Oral Clinical Research (COCR) as the new sponsor and coordinating centre including overarching custodian responsibilities for samples and data collected. 2. Barts Health NHS Trust Dental Hospital where the trial different surgical modalities will take place going forward for all new patients recruited. 3. UCL Eastman Dental Institute where patients already recruited and completed the trial surgical phase will complete their follow up.
A sufficient number of adults (29 per group) presenting; a total of 87 patients with chronic periodontitis and meeting the necessary inclusion and exclusion criteria will be entered into the trial. Subjects will present to the clinical site for initial screening and enrolment (Baseline Visit). Following enrolment, all participants will attend one visit as preparation for the subsequent study treatments. As part of this session, participants will review how to perform efficient self-care regimes at home to remove plaque biofilm accumulations on a regular basis. At this appointment, they will be randomised to their assigned treatment group and the pending treatment will be discussed with them. Treatment groups will consist of simplified papilla preservation flap (SPPF), resective periodontal flap surgery with osseous recontouring (RPFO), or non-surgical subgingival debridement with local anaesthesia (SD). Treatment will take place within 4 weeks of this preparation visit. Participants will then attend for follow-up visits at 1, 2, 3 and 4 weeks post treatment for evaluation of healing, reinforcement of oral hygiene regime, and supra-gingival scale and polish as required. Clinical measurements will be recorded again at 3, 6 and 12 months post treatment. Radiographs will be taken at baseline, and 12 months post treatment. A saliva and plaque sample will be taken at baseline, 3, 6 and 12 months post treatment. GCF will be taken at baseline, 2 weeks and 3 months post treatment. Patient reported outcomes will be evaluated at baseline, 1 week, 3, 6, 9 and 12 months post treatment. Use of NHS and private dental and health services will be collected via self-reported patient diaries distributed at the first intervention appointment, and 3, 6 and 9 months post intervention. Supportive periodontal maintenance visits will be carried out every 3 months for the duration of the study to maintain optimal oral health through monitoring of oral hygiene routine and supra and subgingival scaling and polish as required. A dental prophylaxis will be performed at the end of the study and the study termination form will be completed.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vandana Luthra, Dr.
- Phone Number: +44(0)2078826348
- Email: BHNT.Clinicaloralresearchcentre@nhs.net
Study Contact Backup
- Name: Miljana Bacevic, Dr.
- Phone Number: +44(0)2078826064
- Email: BHNT.Clinicaloralresearchcentre@nhs.net
Study Locations
-
-
-
London, United Kingdom, E1 1BB
- Recruiting
- Barts Health NHS Trust Dental Hospital
-
Contact:
- Nikolaos Donos, DDS, MS, FHEA, PhD
- Phone Number: +44(0)2078823063
- Email: BHNT.Clinicaloralresearchcentre@nhs.net
-
Contact:
- Rinat Ezra Rinat, PhD
- Phone Number: +44(0)207 882 6348
- Email: BHNT.Clinicaloralresearchcentre@nhs.net
-
Principal Investigator:
- Nikolaos Donos, DDS, MS, FHEA, PhD
-
Sub-Investigator:
- Nikolaos Mardas, DDS, MS, PhD
-
Sub-Investigator:
- Nikolaos D Gkranias, DDS, MClinDent, PhD
-
Sub-Investigator:
- Michail Vavalekas, DDM, PhD Cand.
-
Sub-Investigator:
- Efstathios Kousounis, DDS, MClinDent
-
Sub-Investigator:
- Nikolaos Tatarakis, DDS, MS
-
Sub-Investigator:
- Elena Calciolari, DDS, MS, PhD
-
London, United Kingdom, E1 2AD
- Recruiting
- Centre for Oral Clinical Research
-
Contact:
- Nikolaos Donos, DDS, MS, FHEA, PhD
- Phone Number: +44(0)2078823063
- Email: BHNT.Clinicaloralresearchcentre@nhs.net
-
Principal Investigator:
- Nikolaos Donos, DDS, MS, FHEA, PhD
-
Sub-Investigator:
- Nikolaos Mardas, DDS, MS, PhD
-
Sub-Investigator:
- Nikolaos D Gkranias, DDS, MClinDent, PhD
-
Sub-Investigator:
- Efstathios Kousounis, DDS, MClinDent
-
Sub-Investigator:
- Nikolaos Tatarakis, DDS, MS
-
Contact:
- Rinat Ezra, PhD
- Phone Number: +44(0)207 882 6348
- Email: BHNT.Clinicaloralresearchcentre@nhs.net
-
Sub-Investigator:
- Michail Vavalekas, DMD, PhD cand.
-
London, United Kingdom, WC1X 8LD
- Active, not recruiting
- Eastman Clinical Investigation Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Non-surgical subgingival debridement
|
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 Flap with Osseous Recontouring
|
RPFO is a surgical procedure that involves the resection of soft and hard tissue to obtain optimum tissue architecture and pocket reduction or elimination.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical efficacy of 3 different periodontal treatment approaches
Time Frame: 3, 6 and 12 months
|
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
Time Frame: Baseline, 1 week post-op, 3, 6, 9 and 12 months
|
To assess impact on quality of life.
|
Baseline, 1 week post-op, 3, 6, 9 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To investigate the efficacy of 3 different periodontal treatment approaches on PROMs related to general health over a follow-up period of 12 months
Time Frame: Treatment Visit 1, 3, 6 and 9 months
|
To assess impact on general health
|
Treatment Visit 1, 3, 6 and 9 months
|
Incremental cost per quality-adjusted life year gained
Time Frame: 3, 6, 9 and 12 months
|
To determine cost-effectiveness from an NHS perspective
|
3, 6, 9 and 12 months
|
Maintenance/support needs of patients following treatment
Time Frame: 3, 6 and 12 months
|
Measurement of effectiveness of study different treatments
|
3, 6 and 12 months
|
Radiographic bone changes of 3 different periodontal treatment approaches
Time Frame: Baseline and 12 months
|
Linear measurements obtained from standardized peri-apical radiographs
|
Baseline and 12 months
|
Changes in subgingival microbiota
Time Frame: Baseline, 3, 6 and 12 months
|
Assessed via pooled samples and analyzed via Illumina Miseq sequencer
|
Baseline, 3, 6 and 12 months
|
To investigate changes from baseline in saliva inflammatory biomarkers and protein expression
Time Frame: Baseline, 3, 6 and 12 months
|
Proteomic analysis of saliva with LC/MS (liquid chromatography/tandem mass spectrometry)
|
Baseline, 3, 6 and 12 months
|
Facial changes in post-operative swelling and oedema
Time Frame: Right before treatment, 1 week and 2 weeks post-operatively
|
Measurement with 3D imaging technique at different time points following the different periodontal treatments
|
Right before treatment, 1 week and 2 weeks post-operatively
|
To identify the preferred intervention for subgroups of patients based on severity of disease at presentation to secondary care
Time Frame: Treatment Visit 1, 3, 6 and 9 months
|
Assess patient's preference of treatment modality
|
Treatment Visit 1, 3, 6 and 9 months
|
To explore whether outcomes measured at 3 months are sufficiently robust predictors of long-term outcome to be useful in patient management and for monitoring in a timely manner the outcomes being achieved in secondary care
Time Frame: 3 months and 12 months
|
3 months and 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nikolaos Donos, DDS, MS, PhD, Barts & The London School of Medicine & Dentistry, QMUL
- Principal Investigator: Nikolaos Mardas, DDS, MS, PhD, Barts & The London School of Medicine & Dentistry, QMUL
- Principal Investigator: Natalie M Leow, BDS, MDSc, UCL Eastman Dental Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 011467
- COCR0003 (Other Identifier: QMUL)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Periodontitis
-
Columbia UniversityCompletedPeriodontal Diseases | Generalized Moderate Chronic Periodontitis | Generalized Severe Chronic PeriodontitisUnited States
-
Government College of Dentistry, IndoreUnknown
-
Loma Linda UniversityTerminated
-
Jorge GamonalUnknown-Chronic PeriodontitisChile
-
Koite Health OyLithuanian University of Health Sciences; University of HelsinkiRecruitingPeriodontitis Chronic Generalized Moderate | Periodontitis Chronic Generalized SevereLithuania
-
Institute of Biophysics and Cell Engineering of...Belarusian Medical Academy of Post-Graduate EducationCompletedPeriodontitis, ChronicBelarus
-
Institute of Dental Sciences, Bareilly, Uttar Pradesh...UnknownCHRONIC PERIODONTITIS
-
Arab American University (Palestine)CompletedChronic Periodontitis, GeneralizedPalestinian Territory, occupied
-
alaaCompletedGeneralized Chronic Periodontitis
-
Universidade Estadual Paulista Júlio de Mesquita...CompletedChronic Periodontitis ComplexBrazil
Clinical Trials on Non-surgical Subgingival Debridement (SD)
-
Postgraduate Institute of Dental Sciences RohtakNot yet recruitingPeriodontitis | Subgingival PlaqueIndia
-
Postgraduate Institute of Dental Sciences RohtakNot yet recruitingGingival RecessionIndia
-
Postgraduate Institute of Dental Sciences RohtakRecruitingPeriodontal Diseases | Furcation Defects | Open Flap DebridementIndia
-
University of TriesteUnknownPeriodontal Diseases | Anticoagulant-induced BleedingItaly
-
University of CataniaCompleted
-
Tannhelsetjenestens Kompetansesenter for Nord-NorgeMalmö UniversityRecruiting
-
Universitaire Ziekenhuizen KU LeuvenActive, not recruitingSeptic Arthritis of the Native Hip | Failure of Initial DebridementBelgium
-
Universitat Internacional de CatalunyaInstitut Straumann AGRecruitingBone Loss | Peri-Implantitis | Implant ComplicationSpain
-
King's College LondonRecruitingPeriodontitis | Surgical Procedure, Unspecified | Furcation DefectsUnited Kingdom
-
Wuerzburg University HospitalUnknownPeriodontitis | Periodontal Attachment Loss | Periodontal; LesionGermany