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Platelet-Rich Fibrin and Anorganic Bovine Bone vs Collagen Membrane and Anorganic Bovine Bone in Intrabony Defects

Primary Purpose

Periodontal Attachment Loss, Periodontal Bone Loss, Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Periodontal Surgery with PRF+ABB
Periodontal Surgery with Collagen Membrane +ABB
Sponsored by
G. d'Annunzio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Attachment Loss focused on measuring Platelet rich fibrin, bone graft, non inferiority trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • G. d'Annunzio University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PRF+ABB treated patients

Collagen Membrane + ABB treated patients

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Periodontal attachment gain
Reduction of the distance between the cementum-enamel junction and the depth of the probable site

Secondary Outcome Measures

Bone gain
Gain of bone into the periodontal defects

Full Information

First Posted
October 19, 2018
Last Updated
November 18, 2019
Sponsor
G. d'Annunzio University
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1. Study Identification

Unique Protocol Identification Number
NCT03715374
Brief Title
Platelet-Rich Fibrin and Anorganic Bovine Bone vs Collagen Membrane and Anorganic Bovine Bone in Intrabony Defects
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 6, 2017 (Actual)
Primary Completion Date
November 16, 2018 (Actual)
Study Completion Date
December 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
G. d'Annunzio University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary outcome of periodontal reconstructive therapy is to regenerate all tissues of the periodontium including a functional periodontal ligament, alveolar bone and cementum. A number of treatment modalities including the use of bone grafts, guided tissue regeneration (GTR), and the addition of biological agents have been used with large heterogeneity in the clinical and histological outcomes. The rationale of using a filling material when treating unfavorable and large intrabony defects (IBDs) with membranes or biological agents consists of sustaining the overlying soft tissues in the presence of a non-contained defect's architecture, at the same time enhancing the stability of coagulum; and facilitating the proliferation of mesenchymal progenitor cells. Among bone grafts available, anorganic bone bone (ABB) have been widely used in periodontics for the treatment of IBDs In recent years, the increasing understanding of the role of growth factors (GFs) in the wound healing process suggested the use of these biological agents in the regenerative treatment of periodontal bony defects. Noninferiority trials are designed to demonstrate that the effect of a new treatment is adequately similar to an active control by more than a specified margin The aim of this study is to verify if the combined use of PRF (Platelet Rich Fibrin) and ABB in the management of IBDs may be a treatment modality that is clinically "not inferior" compared to the membrane + ABB one, since the combined periodontal regenerative technique has been already tested in literature as a "gold standard" periodontal regenerative technique.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Attachment Loss, Periodontal Bone Loss, Periodontal Diseases
Keywords
Platelet rich fibrin, bone graft, non inferiority trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRF+ABB treated patients
Arm Type
Experimental
Arm Description
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.
Arm Title
Collagen Membrane + ABB treated patients
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Periodontal Surgery with PRF+ABB
Intervention Description
Patients will be treated by periodontal surgical flaps with the addition of PRF+ Anorganic Bovine Bone filling material
Intervention Type
Procedure
Intervention Name(s)
Periodontal Surgery with Collagen Membrane +ABB
Intervention Description
Patients will be treated by periodontal surgical flaps with the addition of Collagen Membrane + Anorganic Bovine Bone filling material
Primary Outcome Measure Information:
Title
Periodontal attachment gain
Description
Reduction of the distance between the cementum-enamel junction and the depth of the probable site
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Bone gain
Description
Gain of bone into the periodontal defects
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
G. d'Annunzio University
City
Chieti
State/Province
CH
ZIP/Postal Code
66100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Platelet-Rich Fibrin and Anorganic Bovine Bone vs Collagen Membrane and Anorganic Bovine Bone in Intrabony Defects

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