- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03715374
Platelet-Rich Fibrin and Anorganic Bovine Bone vs Collagen Membrane and Anorganic Bovine Bone in Intrabony Defects
Treatment of Periodontal Intrabony Defects With Platelet-Rich Fibrin and Anorganic Bovine Bone vs Collagen Membrane and Anorganic Bovine Bone. A Non-Inferiority Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Experimental Design This is a prospective, randomized and controlled clinical trial designed to evaluate the clinical and radiographic outcomes 12 months after two treatment modalities of IBDs: test sites ( TS) will be treated by a combination of PRF and ABB; control sites (CS) will receive the combined treatment of collagen membrane + ABB. The patients enrolled will exhibit unfavorable IBDs and all experimental sites will be accessed with a simplified papilla preservation flap (SPPF) procedure. The filling material (ABB) will be common to both treatments: therefore, the investigation focused on the addictive effect of PRF used instead of COLLAGEN MEMBRANE. Collagen membrane is chosen as the active control (AC) as it is currently considered as the "gold standard" among the biological agents for the treatment of IBDs.
A non-inferiority trial (NIT) is designed to verify whether to use PRF instead of collagen membrane in association with ABB can lead to not inferior therapeutic results, reducing the treatment's cost and allowing the clinicians to use autogenous materials only.
Study Population 62 patients (33 males and 29 females) aged 42 to 64 years (mean: 53±12) seeking treatment at the Unit of Periodontology of the "G. D'Annunzio" University of Chieti- Pescara, Italy, and affected by moderate-to-severe chronic periodontitis, will be selected for the study. The inclusion criteria are: 1) no systemic diseases; 2) no medications affecting periodontal status during the previous 6 months; 3) not pregnant or lactating; 4) non-smoker; and 5) the following dental and periodontal factors: a full-mouth plaque score (FMPS)25 and a full-mouth bleeding score (FMBS)26 < 20% at the time of surgery, no periodontal therapy in the 2 previous years, no inadequate endodontic treatment at the experimental sites, no dental mobility, ≥ 20 teeth, exhibit vertical bone loss detected by radiographic examination ( ACL (alveolar crest level) - (BD bottom of the defect) distance = BDD (Bone defect depth ) ≥ 4 mm and a probing pocket depth (PPD) ≥ 5mm when evaluated 12 weeks after non- surgical therapy [ scaling and root planing ( SRP)]. Only predominantly 1-, combined 1- and 2-, 2-walls defects or teeth with a defect angle ≥ 36° were considered in this study (unfavorable IBDs). To be included in this category, the IBDs should not have a 3-wall component >20% of the total defect depth. The architecture of the defect had to be confirmed by observation during the surgical intervention. Each patient will participate in the study with a single experimental site. In the case that a patient will have more than one IBD with clinical features that could be eligible for study, the most severe defect will be chosen. The participants volunteered for the study after they will receive verbal and written information and signed a consent form approved by the Ethical Committee of the G. D'Annunzio University of Chieti - medical faculty. The study protocol is in accordance with the Declaration of Helsinki of 1975, revised in Tokyo in 2004. The study was performed from February 2013 to December 2016. Four months before the surgical treatment, all 44 patients will undergo SRP by ultrasonic instruments II and hand curettes¶ and motivational instructions on oral home care.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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CH
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Chieti, CH, Italy, 66100
- G. d'Annunzio University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- a full-mouth plaque score (FMPS) 25 and a full-mouth bleeding score (FMBS) 26 < 20% at the time of surgery
- to have at least 20 teeth,;
- at least 1 tooth exhibiting vertical bone loss detected by radiographic examination (alveolar crest level [ ACL]
- bottom of the defect [ BD] distance = Bone defect depth [ BDD]) ≥ 4 mm and a probing pocket depth (PPD) ≥ 5mm when evaluated 12 weeks after phase I non- surgical therapy [ scaling and root planing ( SRP)].
Exclusion Criteria:
- no systemic diseases
- no medications affecting periodontal status during the previous 6 months
- not pregnant or lactating;
- non-smoker
- no periodontal therapy in the 2 previous years,
- no inadequate endodontic treatment, no dental mobility
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PRF+ABB treated patients
Periodontal surgery with Platelet Rich Fibrin is performed, after local anaesthesia, mucoperiosteal SPPFs will be raised.
Anorganic bovine bone material will be applied to the entire root surfaces ; then, A prf membrane is positioned above the filling material.
Finally the flap will be positionated and sutures completed by interrupted sutures.
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Patients will be treated by periodontal surgical flaps with the addition of PRF+ Anorganic Bovine Bone filling material
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Active Comparator: Collagen Membrane + ABB treated patients
Periodontal surgery with collagen membrane is performed, after local anaesthesia, mucoperiosteal SPPFs will be raised.
Anorganic bovine bone material will be applied to the entire root surfaces ; then, A collagen membrane is positioned above the filling material.
Finally the flap will be positionated and sutures completed by interrupted sutures.
|
Patients will be treated by periodontal surgical flaps with the addition of Collagen Membrane + Anorganic Bovine Bone filling material
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Periodontal attachment gain
Time Frame: 1 year
|
Reduction of the distance between the cementum-enamel junction and the depth of the probable site
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bone gain
Time Frame: 1 year
|
Gain of bone into the periodontal defects
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19102018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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