Periodontal DiseasesNCT04254861
Autologous Platelet Concentrate (APC) in Intrabony Defects
A study testing Simplified Papilla Preservation Flap (SPPF) and PRGF ENDORET (PRGF ENDORET®-KMU16) and Simplified Papilla Preservation Flap (SPPF) and GTR in people with Periodontal Diseases, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Simplified Papilla Preservation Flap (SPPF) and PRGF ENDORET (PRGF ENDORET®-KMU16) and Simplified Papilla Preservation Flap (SPPF) and GTR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Mar 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systemically healthy males and females ≥25 years old
- Willingness to read and sign a copy of the Informed Consent Form after reading the Patient Information Sheet, and after the nature of the study has been fully explained
- Clinical evidence of periodontitis, with one interdental area of PPD ≥6mm, BOP, and attachment loss ≥6mm, with associated intrabony defect ≥3mm in any area of their mouth (excluding third molars and distal of second molars)
- Full mouth bleeding and plaque scores (FMBS and FMPS) <25%recorded within the previous 6 weeks
- Non-surgical treatment completed within 6 months prior to assessment for eligibility
Who cannot join
- Medical history that includes diabetes type 1 or hepatic or renal disease, or other serious medical conditions or transmittable diseases (e.g. cardiovascular disease or AIDS).
- Antibiotic or anti-inflammatory therapy during the month preceding the baseline exam.
- In chronic treatment (>2 weeks) with anticoagulants, corticosteroids or other medications that can severely impact on bone formation
- History of alcohol or drug abuse.
- Smoking ≥10 cigarettes a day
- 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.
- Periodontal surgery in the same area selected for the study within the past 12 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Barts and The London Dental Hospital
London, E1 2AD
Rinat Ezra, PhD, 0207 882 6348 ext. 6348, BHNT.Clinicaloralresearchcentre@nhs.net
Archana Archana, MSc, 0207 882 6064 ext. 6064, BHNT.Clinicaloralresearchcentre@nhs.net
About this study
Official title: Regenerative Treatment of Intrabony Defects With GTR and PRGF: A Randomised, Single-blind, Parallel-group Clinical Trial
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.
Read the detailed description
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 -
- Informed consent, medical/dental history and demographics
- Record concomitant medications and smoking history
- Height and weight measurement
- Standardised peri-apical x-ray in the area selected for the study
- Periodontal assessment by a blind and calibrated examiner, consisting of full mouth PPD, REC, BOP, mobility and furcation involvement will be recorded. PPD, REC, plaque and BOP will be recorded at 6 sites per tooth.
- Intra-oral 3D scan in the area selected for the study
- PROMs assessment (OIDP, and Global ratings of Periodontal Health and Quality of Life, EuroQoI-5D-5L)
- 3D extra-oral morphometric and Thermal scan
- Laser speckle contrast imaging, LSCI
- Pre-treatment hygiene phase, including supragingival scale and polish of all teeth and oral hygiene instructions
- Randomization to one of the two treatment groups by the study co-ordinator. The treatment allocation will be concealed in an opaque envelope. A treatment visit will be scheduled within the following 6 weeks.
Visit 2 - Surgical intervention - (within 6 weeks from Visit 1)
- Query to update medical/dental history and record adverse events and/or concomitant medications
- Recording of the number of defect walls
- Study treatment according to randomization (PRGF ENDORET or GTR)
- Intra-oral 3D scan in the area selected for the study (scan taken immediately after surgery)
- Record of surgery time
- Post-surgical instructions
- 3D extra-oral morphometric and thermal scan (scan taken immediately after surgery)
Visit 3 - 2 days follow-up - (2 days ±1 days from Visit 2)
- Query to update medical/dental history and record adverse events and/or concomitant medications
- Visual assessment of gingival healing and recording of early healing index (EHI)
- Laser speckle contrast imaging, LSCI
- Intra-oral 3D scan in the area selected for the study
- 3D extra-oral morphometric and Thermal scan
- PROMs assessment (Evaluation of global changes in quality of life and evaluation of patient perception about therapy)
Visit 4 - Suture removal - (7 days +3 days from visit 2)
- Query to update medical/dental history and record adverse events and/or concomitant medications
- Visual assessment of gingival healing and recording of early healing index (EHI)
- Laser speckle contrast imaging, LSCI
- Intra-oral 3D scan in the area selected for the study
- 3D extra-oral morphometric and Thermal scan
- Suture removal
- Supra-gingival polishing and reinforcement of oral hygiene instructions
- PROMs assessment (Evaluation of global changes in quality of life and evaluation of patient perception about therapy)
Visit 5 - 2 weeks follow up visit- (14 days ±3 days from visit 2)
- Query to update medical/dental history and record adverse events and/or concomitant medications
- Visual assessment of gingival healing and recording of early healing index (EHI)
- Laser speckle contrast imaging, LSCI
- Intra-oral 3D scan in the area selected for the study
- 3D extra-oral morphometric and thermal scan
- Supra-gingival polishing and reinforcement of oral hygiene instructions
- PROMs assessment (Evaluation of global changes in quality of life and evaluation of patient perception about therapy)
Visit 6 - 4 weeks follow up visit- (28 days ±3 days from visit 2)
- Query to update medical/dental history and record adverse events and/or concomitant medications
- Visual assessment of gingival healing
- Intra-oral 3D scan in the area selected for the study
- 3D extra-oral morphometric and Thermal scan
- Supra-gingival polishing and reinforcement of oral hygiene instructions
- PROMs assessment (Global ratings of Periodontal Health and Quality of Life, Evaluation of global changes in quality of life, and Eevaluation of patient perception about therapy and EuroQoI-5D-5L)
Visit 7 - 3 months follow up visit- (3 months ±7 days from visit 2)
- Query to update medical/dental history and record adverse events and/or concomitant medications
- Recording of PPD, REC, BOP, PI and mobility on the tooth involved in the surgical intervention and 2 adjacent teeth by a blind and calibrated examiner
- PROMs assessment (OIDP, Global ratings of Periodontal Health and Quality of Life, and eEvaluation of global changes in quality of life and EuroQoI-5D-5L)
- Supra-gingival polishing and reinforcement of oral hygiene instructions
Visit 8 - 6 months follow up visit- (6 months ±7 days from visit 2)
- Query to update medical/dental history and record adverse events and/or concomitant medications
- Recording of PPD, REC, BOP, PI and mobility on the tooth involved in the surgical intervention and 2 adjacent teeth by a blind and calibrated examiner
- Supra-gingival polishing and reinforcement of oral hygiene instructions
- PROMsS assessment (OIDP, Global ratings of Periodontal Health and Quality of Life, and eEvaluation of global changes in quality of life and EuroQoI-5D-5L)
Visit 9 - 12 months follow up visit- (12 months ±7 days from visit 2)
- Query to update medical/dental history and record adverse events and/or concomitant medications
- Periodontal assessment by a blind and calibrated examiner, consisting of full mouth PPD, REC, BOP, mobility and furcation involvement will be recorded. PPD, REC, plaque and BOP will be recorded at 6 sites per tooth.
- PROMS assessment (OIDP, Global ratings of Periodontal Health and Quality of Life, and eEvaluation of global changes in quality of life and EuroQoI-5D-5L)
- Supra-gingival polishing and reinforcement of oral hygiene instructions
- Standardised peri-apical x-ray in the area selected for the study
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.
- Simplified Papilla Preservation Flap (SPPF) and guided tissue regeneration (GTR) with a porcine collagen membrane and a deproteinized bovine bone substitute.
- Simplified Papilla Preservation Flap (SPPF) and PRGF ENDORET.
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.
- Conditions
- Periodontal Diseases
- Being tested
- Simplified Papilla Preservation Flap (SPPF) and PRGF ENDORET (PRGF ENDORET®-KMU16), Simplified Papilla Preservation Flap (SPPF) and GTR
- Keywords
- Intrabony defect, Periodontitis, PRGF
- Medical subject headings
- Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simplified Papilla Preservation Flap (SPPF) and PRGF ENDORET (PRGF ENDORET®-KMU16)Procedure or surgery
Also called 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.
Simplified Papilla Preservation Flap (SPPF) and GTRProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Simplified Papilla Preservation Flap (SPPF) and PRGF | Experimental | Not described Receives: Procedure: Simplified Papilla Preservation Flap (SPPF) and PRGF ENDORET (PRGF ENDORET®-KMU16) |
| Simplified Papilla Preservation Flap (SPPF) and GTR | Active comparator | Not described Receives: Procedure: Simplified Papilla Preservation Flap (SPPF) and GTR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changed in Probing Pocket Depth (PPD)
Changes in PPD from baseline to 12 months after treatment
Measured: 12 months after treatment
Secondary outcomes (7)
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.
Measured: 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
Measured: 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:
- 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:
- Excellent
- Very good
- Good
- Fair
- Poor
- Very poor
PROMs based on the evaluation of global changes in quality of life;
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: From baseline to 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start2 Mar 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254861
- Sponsor's protocol ID
- IRAS Project ID: 259229
- Other IDs
- COCR0021
- Status last verified
- Jul 2026
- First submitted
- 27 Jan 2020
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regenerative Treatment of Intrabony Defects With GTR and PRGF: A Randomised, Single-blind, Parallel-group Clinical Trial
- ClinicalTrials.gov ID
- NCT04254861
- Acronym / sponsor ID
- IRAS Project ID: 259229
- Conditions
- Periodontal Diseases
- Keywords
- Intrabony defect, Periodontitis, PRGF
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Feb 2020 (actual)
- 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 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.
Detailed description
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 -
- Informed consent, medical/dental history and demographics
- Record concomitant medications and smoking history
- Height and weight measurement
- Standardised peri-apical x-ray in the area selected for the study
- Periodontal assessment by a blind and calibrated examiner, consisting of full mouth PPD, REC, BOP, mobility and furcation involvement will be recorded. PPD, REC, plaque and BOP will be recorded at 6 sites per tooth.
- Intra-oral 3D scan in the area selected for the study
- PROMs assessment (OIDP, and Global ratings of Periodontal Health and Quality of Life, EuroQoI-5D-5L)
- 3D extra-oral morphometric and Thermal scan
- Laser speckle contrast imaging, LSCI
- Pre-treatment hygiene phase, including supragingival scale and polish of all teeth and oral hygiene instructions
- Randomization to one of the two treatment groups by the study co-ordinator. The treatment allocation will be concealed in an opaque envelope. A treatment visit will be scheduled within the following 6 weeks.
Visit 2 - Surgical intervention - (within 6 weeks from Visit 1)
- Query to update medical/dental history and record adverse events and/or concomitant medications
- Recording of the number of defect walls
- Study treatment according to randomization (PRGF ENDORET or GTR)
- Intra-oral 3D scan in the area selected for the study (scan taken immediately after surgery)
- Record of surgery time
- Post-surgical instructions
- 3D extra-oral morphometric and thermal scan (scan taken immediately after surgery)
Visit 3 - 2 days follow-up - (2 days ±1 days from Visit 2)
- Query to update medical/dental history and record adverse events and/or concomitant medications
- Visual assessment of gingival healing and recording of early healing index (EHI)
- Laser speckle contrast imaging, LSCI
- Intra-oral 3D scan in the area selected for the study
- 3D extra-oral morphometric and Thermal scan
- PROMs assessment (Evaluation of global changes in quality of life and evaluation of patient perception about therapy)
Visit 4 - Suture removal - (7 days +3 days from visit 2)
- Query to update medical/dental history and record adverse events and/or concomitant medications
- Visual assessment of gingival healing and recording of early healing index (EHI)
- Laser speckle contrast imaging, LSCI
- Intra-oral 3D scan in the area selected for the study
- 3D extra-oral morphometric and Thermal scan
- Suture removal
- Supra-gingival polishing and reinforcement of oral hygiene instructions
- PROMs assessment (Evaluation of global changes in quality of life and evaluation of patient perception about therapy)
Visit 5 - 2 weeks follow up visit- (14 days ±3 days from visit 2)
- Query to update medical/dental history and record adverse events and/or concomitant medications
- Visual assessment of gingival healing and recording of early healing index (EHI)
- Laser speckle contrast imaging, LSCI
- Intra-oral 3D scan in the area selected for the study
- 3D extra-oral morphometric and thermal scan
- Supra-gingival polishing and reinforcement of oral hygiene instructions
- PROMs assessment (Evaluation of global changes in quality of life and evaluation of patient perception about therapy)
Visit 6 - 4 weeks follow up visit- (28 days ±3 days from visit 2)
- Query to update medical/dental history and record adverse events and/or concomitant medications
- Visual assessment of gingival healing
- Intra-oral 3D scan in the area selected for the study
- 3D extra-oral morphometric and Thermal scan
- Supra-gingival polishing and reinforcement of oral hygiene instructions
- PROMs assessment (Global ratings of Periodontal Health and Quality of Life, Evaluation of global changes in quality of life, and Eevaluation of patient perception about therapy and EuroQoI-5D-5L)
Visit 7 - 3 months follow up visit- (3 months ±7 days from visit 2)
- Query to update medical/dental history and record adverse events and/or concomitant medications
- Recording of PPD, REC, BOP, PI and mobility on the tooth involved in the surgical intervention and 2 adjacent teeth by a blind and calibrated examiner
- PROMs assessment (OIDP, Global ratings of Periodontal Health and Quality of Life, and eEvaluation of global changes in quality of life and EuroQoI-5D-5L)
- Supra-gingival polishing and reinforcement of oral hygiene instructions
Visit 8 - 6 months follow up visit- (6 months ±7 days from visit 2)
- Query to update medical/dental history and record adverse events and/or concomitant medications
- Recording of PPD, REC, BOP, PI and mobility on the tooth involved in the surgical intervention and 2 adjacent teeth by a blind and calibrated examiner
- Supra-gingival polishing and reinforcement of oral hygiene instructions
- PROMsS assessment (OIDP, Global ratings of Periodontal Health and Quality of Life, and eEvaluation of global changes in quality of life and EuroQoI-5D-5L)
Visit 9 - 12 months follow up visit- (12 months ±7 days from visit 2)
- Query to update medical/dental history and record adverse events and/or concomitant medications
- Periodontal assessment by a blind and calibrated examiner, consisting of full mouth PPD, REC, BOP, mobility and furcation involvement will be recorded. PPD, REC, plaque and BOP will be recorded at 6 sites per tooth.
- PROMS assessment (OIDP, Global ratings of Periodontal Health and Quality of Life, and eEvaluation of global changes in quality of life and EuroQoI-5D-5L)
- Supra-gingival polishing and reinforcement of oral hygiene instructions
- Standardised peri-apical x-ray in the area selected for the study
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.
- Simplified Papilla Preservation Flap (SPPF) and guided tissue regeneration (GTR) with a porcine collagen membrane and a deproteinized bovine bone substitute.
- Simplified Papilla Preservation Flap (SPPF) and PRGF ENDORET.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Simplified Papilla Preservation Flap (SPPF) and PRGF | Experimental | Procedure: Simplified Papilla Preservation Flap (SPPF) and PRGF ENDORET (PRGF ENDORET®-KMU16) |
| Simplified Papilla Preservation Flap (SPPF) and GTR | Active comparator | Procedure: Simplified Papilla Preservation Flap (SPPF) and GTR |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Systemically healthy males and females ≥25 years old
- Willingness to read and sign a copy of the Informed Consent Form after reading the Patient Information Sheet, and after the nature of the study has been fully explained
- Clinical evidence of periodontitis, with one interdental area of PPD ≥6mm, BOP, and attachment loss ≥6mm, with associated intrabony defect ≥3mm in any area of their mouth (excluding third molars and distal of second molars)
- Full mouth bleeding and plaque scores (FMBS and FMPS) <25%recorded within the previous 6 weeks
- Non-surgical treatment completed within 6 months prior to assessment for eligibility
Key exclusion criteria (8 listed)
- Medical history that includes diabetes type 1 or hepatic or renal disease, or other serious medical conditions or transmittable diseases (e.g. cardiovascular disease or AIDS).
- Antibiotic or anti-inflammatory therapy during the month preceding the baseline exam.
- In chronic treatment (>2 weeks) with anticoagulants, corticosteroids or other medications that can severely impact on bone formation
- History of alcohol or drug abuse.
- Smoking ≥10 cigarettes a day
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 |
|---|---|---|
| Simplified Papilla Preservation Flap (SPPF) and PRGF ENDORET (PRGF ENDORET®-KMU16)Also: Simplified Papilla Preservation Flap (SPPF) and GTRA 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. | Procedure or surgery | Simplified Papilla Preservation Flap (SPPF) and PRGF |
| Simplified Papilla Preservation Flap (SPPF) and GTRA 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. | Procedure or surgery | Simplified Papilla Preservation Flap (SPPF) and GTR |
Primary outcome
Changed in Probing Pocket Depth (PPD)
Time frame: 12 months after treatment
Changes in PPD from baseline to 12 months after treatment
7 secondary outcomes
Patients' reported outcomes (PROMs) in Oral Impact on Daily Performances (OIDP) questionnaire (OIDP).
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
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
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
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
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
Time frame: At baseline and 2, 7 and 14 days after surgical intervention (visit 2)
Radiographic bone changes
Time frame: From baseline to 12 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simplified Papilla Preservation Flap (SPPF) and PRGF ENDORET (PRGF ENDORET®-KMU16) and Simplified Papilla Preservation Flap (SPPF) and GTR in people with Periodontal Diseases, run by Queen Mary University of London at 1 site 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena Calciolari, PhD (0207 882 3134, e.calciolari@qmul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changed in Probing Pocket Depth (PPD) (time frame: 12 months after treatment). 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 6 Jul 2026.