An interventional study of Simplified Papilla Preservation Flap (SPPF) and PRGF ENDORET (PRGF ENDORET®-KMU16) and Simplified Papilla Preservation Flap (SPPF) and GTR in Periodontal Diseases, sponsored by Queen Mary University of London. Recruiting at 1 site in United Kingdom. Open to participants aged 25 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Queen Mary University of London · Not applicable, Interventional, and Treatment
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Among 18 studies in Periodontal Diseases with a site in United Kingdom — 9 open to participants now, 9 under way, none of them phase 3. Periodontal Diseases · United Kingdom.
Among the 18 studies in Periodontal Diseases with a site in United Kingdom, this one is the 3rd largest by planned enrollment of the 11 interventional ones that give a count, is the only one that started in 2021, is one of 9 with no phase, and was the 9th registered.
867 studies on the registry are indexed under Periodontal Diseases; 189 are open to participants now.
Browse Periodontal Diseases studies →9 of the 18 studies in Periodontal Diseases with a site in United Kingdom are open now. Recruiting first, the newest first:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Sites in United Kingdom, China, Italy
Ages 18+ · Healthy volunteers
Mahdi Mutahar · Sites in United Kingdom
Ages 30–75
University of Plymouth · Sites in United Kingdom
Ages 18+
Queen Mary University of London · Sites in United Kingdom
Ages 18+
King's College London · Sites in United Kingdom
Ages 18+ · Healthy volunteers
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 101 Periodontal Diseases studies recruiting now, 47 (47%) set no upper age limit and 42 (42%) stop at 75 or younger; 5 take children under 18; 58 take healthy volunteers.
This study: 25 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
18 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 1 started in 2021.
This study's planned enrollment of 74 is above the median of 45 across 557 interventional studies indexed under Periodontal Diseases.
Median enrollment 40 across the 11 interventional studies, 215 across the 7 observational. Of the 5 that completed or were terminated, 1 (20%) have results posted.
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1 of 18 have an industry lead sponsor. The 10 most frequent:
Queen Mary University of London is the lead sponsor of 253 studies on the registry; 58 are open to participants now.
Queen Mary University of London has 2 studies filed under Periodontal Diseases — fewer than ten, so there is no comparison to draw.
4 of the studies in Periodontal Diseases with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06309719Queen Mary University of LondonHyaluronic Acid and Polynucleotides for Supra-bony Defects | 2026-12 |
| NCT04254861Queen Mary University of LondonAutologous Platelet Concentrate (APC) in Intrabony Defects | 2026-12-31 |
| NCT04719026University of AberdeenPERIODONTAL HEALTH IN PATIENTS ACUTELY ADMITTED FOR MYOCARDIAL INFARCTION: A CASE CONTROL STUDY | 2027-03-14 |
| NCT07203872Guy's and St Thomas' NHS Foundation TrustInflammation-resolution Therapy in MINST of Periodontal Intrabony Defect: a Pilot Randomised Controlled Trial | 2027-05-01 |
Add all 4 to your calendar (.ics) → With an account.
Among the 18 studies in Periodontal Diseases with a site in United Kingdom, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The aim of this 12-month clinical study is to treat patients affected by gum disease (periodontitis) by a minor gum surgery that aims to reduce the depth of the gum pockets. In particular, the study will compare two types of gum surgery, one based on the use of a product derived from the patients' own blood (PRGF, platelet autologous concentrate), and the other based on the use of an animal-derived bone graft and membrane that have been in the market for the past 30 years. Both procedures aim to regenerate bone and gum tissue that is damaged by the disease. 74, ≥ 25-year-old, otherwise healthy, patients affected by gum disease will be recruited at the Barts and The London Dental Hospital. Participants will be randomly (by chance) assigned to receive one of the two treatments. Throughout the study, we will assess gum's health by taking some measurements around teeth and gums. In addition, we will use non-invasive technologies to assess changes in temperature, blood flow and face's swelling at different time-points. Patients will be given specific questionnaires to evaluate their preferences and the impact that each surgical treatment had in their everyday life. One intra-oral x-ray will be performed before the surgery and after 12 months to assess if new bone has formed around the teeth involved in the surgery, as per standard procedure.
This is a randomized, single-blind, parallel-group controlled trial comparing the efficacy of GTR and PRGF ENDORET in the treatment of periodontal intrabony defects. The trial will follow the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) statement.
No negative control (SPPF alone) has been considered for this project since several studies have demonstrated that guided tissue regeneration (GTR) associated or not with bone grafts results in better clinical outcomes than access flap alone in the treatment of periodontal intrabony defects.
The study consists of 9 visits over a minimum period of 13 months and will take place at the Centre for Oral Clinical Research (COCR), at the Institute of Dentistry, Barts and The London School of Medicine and Dentistry, Queen Mary University of London.
Visit 1 - Baseline -
Visit 2 - Surgical intervention - (within 6 weeks from Visit 1)
Visit 3 - 2 days follow-up - (2 days ±1 days from Visit 2)
Visit 4 - Suture removal - (7 days +3 days from visit 2)
Visit 5 - 2 weeks follow up visit- (14 days ±3 days from visit 2)
Visit 6 - 4 weeks follow up visit- (28 days ±3 days from visit 2)
Visit 7 - 3 months follow up visit- (3 months ±7 days from visit 2)
Visit 8 - 6 months follow up visit- (6 months ±7 days from visit 2)
Visit 9 - 12 months follow up visit- (12 months ±7 days from visit 2)
Study randomisation and treatment allocation Following completion of the preparation treatment all individuals enrolled into the study will be randomly assigned to one of the treatment groups.
A balanced random permuted block approach (4-unit block size) will be used to prepare the randomisation tables. Minimisation will be carried out to facilitate balancing of smokers in each group.
Allocation to treatment will take place via the study coordinator (or one of their delegate). Treatment allocation details will be concealed in an opaque envelope at the study site.
At the time of enrollment, each participant will be sequentially issued a subject ID. The subject ID consists of two initials and a number. The ID number will consist of three digits and will be assigned in ascending numerical order beginning with 001.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Simplified Papilla Preservation Flap (SPPF) and PRGF ENDORET (PRGF ENDORET®-KMU16)
Procedure: Simplified Papilla Preservation Flap (SPPF) and GTR
A simplified papilla preservation flap (SPPF) will be performed. The clot phase of PRGF ENDORET (F2) will be placed in the defect, while the fibrin membrane phase (F1) will cover it. Blood will be extracted and collected in dedicated tubes and then centrifuged. Up to 8 tubes of 9ml will be extracted. The time from the start of the extraction to the start of the centrifugation of the tubes must not exceed 4mins. After centrifugation, the blood is separated into three components: Plasma rich in growth factors, White cells or leukocytes, red blood cells: this is the red column occupying the bottom of the tube. Following BTI's instructions, fractioning of the centrifuged blood will be performed in order to separate Fraction 2 (F2), which contains a greater number of platelets and growth factors and will be used as a clot inside the periodontal defect from Fraction 1 (F1), which will be used as a fibrin member to cover the clot. The flaps will be repositioned and sutured.
Also known as: Simplified Papilla Preservation Flap (SPPF) and GTR
A simplified papilla preservation flap (SPPF) will be performed. The defect will then be treated according to the guided tissue regeneration (GTR) principle (control group). A deproteinized bovine bone mineral (DBBM) graft will be placed in the defect and covered by a collagen membrane.
Changed in Probing Pocket Depth (PPD)
Changes in PPD from baseline to 12 months after treatment
Time frame: 12 months after treatment
Patients' reported outcomes (PROMs) in Oral Impact on Daily Performances (OIDP) questionnaire (OIDP).
The OIDP is a well validated and frequently used PROM in studies of oral health. It is a composite measure of the impacts of oral health on the quality of life of people. The OIDP focuses on the impact that the conditions of the teeth and mouth have on the physical (functional), psychological and social wellbeing of the person. More specifically, it assesses the impact of oral conditions on basic daily life activities and behaviours (eating, speaking, cleaning teeth, going out, relaxing, smiling, major work or role, emotional stability, social contact). For each performance, both the frequency and severity of oral impacts are assessed. The overall OIDP score ranges from 0 to 100, with higher scores indicating worse quality of life.
Time frame: At baseline, 3 months after surgery (visits 2), 6 months after surgery, 12 months after surgery.
PROMs based on Global ratings of Periodontal Health and Quality of Life
PROMs based on Global ratings of Periodontal Health and Quality of Life
Time frame: At baseline, 4 weeks after surgery (visit 2), 3 months after surgery, 6 months after surgery, 12 months after surgery.
PROMs based on the evaluation of global changes in quality of life
Global ratings on health and quality of life will be provided through two methods: a) the Visual Analogue Scale (VAS) included in the EQ5D questionnaire. b) through the following question: 'How would you rate the quality of your life'? The responses will be scored on a six-point scale as: 1. Excellent 2. Very good 3. Good 4. Fair 5. Poor 6. Very poor PROMs based on the evaluation of global changes in quality of life;
Time frame: At baseline, 2 days after surgery (visit 2), 7 days after surgery, 14 days after surgery, 4 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery.
PROMs based on the evaluation of patient perception about therapy
The extent of discomfort and/or pain experienced will be evaluated using a 100-mm horizontal visual analog scale (VAS). The anchors for each end of the scales will be designated as none and extreme. Patients will be also instructed to quantify the analgesic medication taken. In addition, the extent of discomfort, root hypersensitivity, oedema, hematoma, high fever, and interference in daily activities during the first post-therapy week will be evaluated in the same way.
Time frame: At baseline, 2 days after surgery (visit 2), 7 days after surgery, 14 days after surgery, 4 weeks after surgery.
Post-operative swelling and oedema
A series of subtracted images from the baseline will accurately identify the area and magnitude of the swelling, changes in facial shape, volume and temperature to monitor/quantify the healing. For every patient, a person specific template of postoperative facial swelling/ oedema pattern will be created for sequential swelling/thermal changes or oedema volume measurements that will be applied on a unique alignment of the patient's specific consecutive imaging surfaces (self- defined positioning based on patient's facial features).
Time frame: At baseline, within 6 weeks from baseline (at visit 2 - surgical intervention), 2, 7 and 14 days after surgical intervention (visit 2)
Changes in blood flow
The vascularization pattern of the peri-implant soft tissues will be evaluated with Laser Speckle Contrast Imaging (LSCI), according to the methodology described by previous studies. LSCI is a radiation-free, non-invasive procedure to assess blood flow. Systolic and diastolic blood pressure as well as pulse rate will be measured with an automatic blood pressure monitor before and after the LSCI measurements. These measures will be combined to give a measure of blood flow to assess patients' vascularization pattern of the peri-implant soft tissues. Each patient will seat comfortably in supine position in a dental chair, and a vacuum pillow will be used for fixing their head. The patient will be left undisturbed for 15 minutes before any measurements will be taken. All measurements will be carried out at a constant room temperature.
Time frame: At baseline and 2, 7 and 14 days after surgical intervention (visit 2)
Radiographic bone changes
Standardised intraoral radiographs will be taken on the tooth involved in the surgical intervention at baseline and at 12 months post treatment.
Time frame: From baseline to 12 months post-surgery
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2021 (actual). Primary completion is estimated for Dec 2026, 69 months after the start.
Of 312 non-industry interventional studies with no phase under Periodontal Diseases, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 27. This study's planned 69 months is above that.
Counting every sponsor, half of 331 studies reached it within 13 months; a quarter within 8 and three quarters within 27.
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