Autologous Platelet Concentrate (APC) in Intrabony Defects
Regenerative Treatment of Intrabony Defects With GTR and PRGF: A Randomised, Single-blind, Parallel-group Clinical Trial
2 other identifiers
interventional
74
1 country
1
Brief 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, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedStudy Start
First participant enrolled
March 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
June 8, 2025
June 1, 2025
5.8 years
January 27, 2020
June 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changed in Probing Pocket Depth (PPD)
Changes in PPD from baseline to 12 months after treatment
12 months after treatment
Secondary Outcomes (7)
Patients' reported outcomes (PROMs) in Oral Impact on Daily Performances (OIDP) questionnaire (OIDP).
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
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
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
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
At baseline, within 6 weeks from baseline (at visit 2 - surgical intervention), 2, 7 and 14 days after surgical intervention (visit 2)
- +2 more secondary outcomes
Study Arms (2)
Simplified Papilla Preservation Flap (SPPF) and PRGF
EXPERIMENTALSimplified Papilla Preservation Flap (SPPF) and GTR
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Barts and The London Dental Hospital
London, E1 2AD, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Due to the nature of the intervention, both participants and clinicians performing the surgical intervention will be unblinded. Conversely, outcome examiners will be blinded to treatment allocation.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2020
First Posted
February 5, 2020
Study Start
March 2, 2021
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
June 8, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share