Autologous Platelet Concentrate (APC) in Intrabony Defects
ConditionPeriodontal Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-80
SponsorQueen Mary University of London
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Simplified Papilla Preservation Flap (SPPF) and PRGF ENDORET (PRGF ENDORET®-KMU16)
Procedure/SurgeryA 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 GTR
Procedure/SurgeryA 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.
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: Simplified Papilla Preservation Flap (SPPF) and PRGFExperimental treatment 1 intervention
Group B: Simplified Papilla Preservation Flap (SPPF) and GTRActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changed in Probing Pocket Depth (PPD)
Changes in PPD from baseline to 12 months after treatment
Time frame
12 months after treatmentSecondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov