Advanced Platelet Rich Fibrin in Periodontal Angular Defects

Sponsor
Alexandria University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03433066
Collaborator
(none)
22
1
2
15
1.5

Study Details

Study Description

Brief Summary

The aim of this study is to clinically and radiographically evaluate the efficacy of advanced platelet-rich fibrin (A-PRF) when used with biphasic alloplast in the management of intrabony defects in patients with moderate to severe chronic periodontitis.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Advanced platelet-rich fibrin mixed with biphasic alloplast
  • Procedure: Biphasic alloplast mixed with saline
N/A

Detailed Description

Biphasic alloplasts have been successfully used in management of intrabony defects. Advanced platelet-rich fibrin is believed to contain higher amount of growth factors and white blood cells than the well known PRF. Although there are some studies on the use of PRF in the treatment of intrabony defects, to date none of them evaluate the effect of the A-PRF. Therefore, a randomized controlled clinical trial was conducted to compare the healing of intrabony defects treated with A-PRF/biphasic alloplast combination and to those obtained with biphasic alloplast mixed with saline. Using a parallel arm design, 22 intrabony defects were randomly treated with either biphasic alloplast mixed with saline (control group) or with A-PRF/ biphasic alloplast combination (test group). The following clinical parameters were recorded at baseline, three and six months postoperatively : plaque index (PI), modified gingival index (MGI), probing depth (PD), clinical attachment level (CAL), while these radiographic measurements were recorded at baseline and six months postoperatively: bone fill and bone density.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This clinical study will be conducted on twenty-two (22) interproximal intrabony defects in patients with moderate to severe chronic periodontitis.These patients will be divided randomly into two groups: Group I: (test) will include eleven interproximal intrabony defects that will be treated with (Advanced platelet rich fibrin & biphasic alloplast) Group II: (control) will include eleven interproximal intrabony defects that will be treated with (biphasic alloplast mixed with saline.)This clinical study will be conducted on twenty-two (22) interproximal intrabony defects in patients with moderate to severe chronic periodontitis.These patients will be divided randomly into two groups:Group I: (test) will include eleven interproximal intrabony defects that will be treated with (Advanced platelet rich fibrin & biphasic alloplast) Group II: (control) will include eleven interproximal intrabony defects that will be treated with (biphasic alloplast mixed with saline.)
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluation of Advanced Platelet-rich Fibrin in Management of Periodontal Intrabony Defects
Actual Study Start Date :
Mar 1, 2018
Anticipated Primary Completion Date :
Mar 1, 2019
Anticipated Study Completion Date :
Jun 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: group I (Test)

Advanced platelet-rich fibrin mixed with biphasic alloplast

Procedure: Advanced platelet-rich fibrin mixed with biphasic alloplast
mucoperiosteal flaps will be reflected to expose the defects , which will be debrided properly and finally filled with the freshly prepared Advanced platelet-rich fibrin mixed with the biphasic alloplast.

Active Comparator: Group II (control)

Biphasic alloplast mixed with saline

Procedure: Biphasic alloplast mixed with saline
mucoperiosteal flap will be reflected to expose and clean the intrabony defect ,then it will be filled with biphasic alloplast mixed with saline.

Outcome Measures

Primary Outcome Measures

  1. Clinical attachment level change [Baseline , 3 and 6 months posoperatively]

    The distance from cemento-enamel junction to the depth of the sulcus recorded by a periodontal probe at baseline , 3 and 6 months postoperatively

Secondary Outcome Measures

  1. Probing depth change: [Baseline , 3 and 6 months postoperatively]

    The distance from the gingival margin to the depth of the sulcus recorded by a periodontal probe at baseline and 6 months postoperatively

  2. Radiographic bone density [Baseline and 6 months postoperatively]

    Measuring the bone density before and after the procedure using CBCT

  3. Radiographic bone fill [Baseline and 6 months postoperatively]

    The actual bone formation in the intrabony defect measured on a CBCT in comparison to the baseline CBCT

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • They should be diagnosed as having moderate -severe chronic periodontitis according to the American Academy of Periodontology classification on gingival and periodontal diseases (1999)

  • Clinical attachment loss (CAL) ,radiographic evidence of the presence of at least one intrabony defect.

  • Patient's age between 25 to 55 years.

  • Both sexes.

  • No periodontal surgeries in the area of interest during the previous 6 months.

  • The presence of intrabony defects (IBD) ≥3 mm deep (distance between alveolar crest and deepest point in the defect estimated from radiographs and confirmed upon surgical exposure).

  • An interproximal probing depth (PD) ≥5 mm and clinical attachment loss (CAL) ≥3mm after phase I therapy in maxillary/ mandibular teeth.

  • The presence of an adequate zone of keratinized gingiva at the facial aspect of the selected tooth.

Exclusion Criteria:
  • Patients who could not maintain O'leary plaque index (54) ≤10% after phase I therapy.

  • Aggressive periodontitis patients.

  • Patients with systemic conditions known to affect the periodontal status, or, under medications known to affect the outcomes of periodontal therapy.

  • Pregnancy/lactation.

  • Smoking and tobacco use in any form.

  • Non vital teeth and teeth with grade III mobility.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Periodontology department, Faculty of Dentistry, Alexandria University Alexandria Egypt 21500

Sponsors and Collaborators

  • Alexandria University

Investigators

  • Study Chair: Mohy Eldin A. ElRashidy, Professor,

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jaylane kadry Ghonima, Instructor Jaylane Kadry Ghonima, Alexandria University
ClinicalTrials.gov Identifier:
NCT03433066
Other Study ID Numbers:
  • platelet rich fibrin
First Posted:
Feb 14, 2018
Last Update Posted:
Feb 5, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jaylane kadry Ghonima, Instructor Jaylane Kadry Ghonima, Alexandria University

Study Results

No Results Posted as of Feb 5, 2019