Chronic PeriodontitisNCT01642641
Different Surgical Modalities in the Treatment of Periodontitis
A study testing Non-surgical Subgingival Debridement (SD), Simplified Papilla Preservation Flap and Resective Periodontal Flap with Osseous Recontouring (RPFO) in people with Chronic Periodontitis, run by Queen Mary University of London at 3 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Non-surgical Subgingival Debridement (SD), Simplified Papilla Preservation Flap and Resective Periodontal Flap with Osseous Recontouring (RPFO)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 30 Oct 2016to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Barts Health NHS Trust Dental Hospital
London, E1 1BB
Centre for Oral Clinical Research
London, E1 2AD
Eastman Clinical Investigation Centre
London, WC1X 8LD
About this study
Official title: The Efficacy of Different Surgical Modalities in the Treatment of Periodontitis. A Randomised Controlled Trial
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.
Read the 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.
- Conditions
- Chronic Periodontitis
- Being tested
- Non-surgical Subgingival Debridement (SD), Simplified Papilla Preservation Flap, Resective Periodontal Flap with Osseous Recontouring (RPFO)
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical Subgingival Debridement (SD)Procedure or surgery
SD is a conservative non-surgical procedure aimed at reducing dental plaque and calculus from the tooth root usually under local anaesthesia.
Simplified Papilla Preservation FlapProcedure or surgery
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.
Resective Periodontal Flap with Osseous Recontouring (RPFO)Procedure or surgery
RPFO is a surgical procedure that involves the resection of soft and hard tissue to obtain optimum tissue architecture and pocket reduction or elimination.
| Study group | Role | What they receive |
|---|---|---|
| Non-surgical subgingival debridement | Active comparator | Not described Receives: Procedure: Non-surgical Subgingival Debridement (SD) |
| Simplified Papilla Preservation Flap | Active comparator | Not described Receives: Procedure: Simplified Papilla Preservation Flap |
| Resective Flap with Osseous Recontouring | Active comparator | Not described Receives: Procedure: Resective Periodontal Flap with Osseous Recontouring (RPFO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy of 3 different periodontal treatment approaches
A clinical measure of resolution of disease from baseline in Periodontal Probing Depths (PPD)
Measured: 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.
Measured: 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
To assess impact on general health
Measured: Treatment Visit 1, 3, 6 and 9 months
Incremental cost per quality-adjusted life year gained
To determine cost-effectiveness from an NHS perspective
Measured: 3, 6, 9 and 12 months
Maintenance/support needs of patients following treatment
Measurement of effectiveness of study different treatments
Measured: 3, 6 and 12 months
Radiographic bone changes of 3 different periodontal treatment approaches
Linear measurements obtained from standardized peri-apical radiographs
Measured: Baseline and 12 months
Changes in subgingival microbiota
Assessed via pooled samples and analyzed via Illumina Miseq sequencer
Measured: Baseline, 3, 6 and 12 months
To investigate changes from baseline in saliva inflammatory biomarkers and protein expression
Proteomic analysis of saliva with LC/MS (liquid chromatography/tandem mass spectrometry)
Measured: Baseline, 3, 6 and 12 months
Facial changes in post-operative swelling and oedema
Measurement with 3D imaging technique at different time points following the different periodontal treatments
Measured: 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
Assess patient's preference of treatment modality
Measured: 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
Measured: 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study start30 Oct 2016
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikolaos Donos, DDS, MS, PhD, Study director, Barts & The London School of Medicine & Dentistry, QMULNikolaos Mardas, DDS, MS, PhD, Principal investigator, Barts & The London School of Medicine & Dentistry, QMULNatalie M Leow, BDS, MDSc, Principal investigator, UCL Eastman Dental Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642641
- Sponsor's protocol ID
- 011467
- Other IDs
- COCR0003
- Status last verified
- Mar 2025
- First submitted
- 11 Jul 2012
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Different Surgical Modalities in the Treatment of Periodontitis. A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01642641
- Acronym / sponsor ID
- 011467
- Conditions
- Chronic Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 30 Oct 2016 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 17 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Non-surgical subgingival debridement |
| Simplified Papilla Preservation FlapThe 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. | Procedure or surgery | Simplified Papilla Preservation Flap |
| 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. | Procedure or surgery | Resective Flap with Osseous Recontouring |
Primary outcome
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)
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.
9 secondary outcomes
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
Incremental cost per quality-adjusted life year gained
Time frame: 3, 6, 9 and 12 months
Maintenance/support needs of patients following treatment
Time frame: 3, 6 and 12 months
Radiographic bone changes of 3 different periodontal treatment approaches
Time frame: Baseline and 12 months
Changes in subgingival microbiota
Time frame: 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
Facial changes in post-operative swelling and oedema
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolaos Donos, DDS, MS, PhD study director
Barts & The London School of Medicine & Dentistry, QMUL
Nikolaos Mardas, DDS, MS, PhD principal investigator
Barts & The London School of Medicine & Dentistry, QMUL
Natalie M Leow, BDS, MDSc principal investigator
UCL Eastman Dental Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-surgical Subgingival Debridement (SD), Simplified Papilla Preservation Flap and Resective Periodontal Flap with Osseous Recontouring (RPFO) in people with Chronic Periodontitis, run by Queen Mary University of London at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical efficacy of 3 different periodontal treatment approaches (time frame: 3, 6 and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.