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Concentrated Growth Factors in Treatment of Intrabony Defects in Localized Aggressive Periodontitis (RCT)

Primary Purpose

Aggressive Periodontitis

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
GTR
concentrated growth factor
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aggressive Periodontitis focused on measuring aggressive periodontitis, intrabony defect,, concentrated growth factors membrane

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Presence of angular periodontal intra-bony defects with clinical attachment loss ≥5 mm measured from CEJ to the deepest propping depth with no evidence of gingival recession
  • optimal compliance as evidenced by no missed treatment appointment and high attitude towards oral hygiene

Exclusion Criteria:

  • Patients with relevant medical conditions that may affect periodontal regeneration and surgery
  • smokers, pregnant or lactating women
  • those whom periodontal surgery had previously been carried out on the selected site,
  • and patients who taking any drug known to affect the number or function of platelets

Sites / Locations

  • Malak Yousef Mohamed Shoukheba

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

collagen membrane

Concentrated growth factor membrane

Arm Description

10 sites treated with surgery and bone graft and collagen membrane as GTR

10 sites treated by surgery +bone graft and concentrated growth factor membrane as GTR

Outcomes

Primary Outcome Measures

probing pocket depth
measured from the gingival margin to the base of the pocket using periodontal probe in mm
clinical attachment level
measured from the cemento-enamel junction to the base of the pocket using periodontal probe in mm
radiographic defect area by cone beam x ray
measured in square millimeter from cone beam x ray
radiographic bone density by cone beam
By Hounsfield unit from the cone beam x ray

Secondary Outcome Measures

bleeding on probing
bleeding on probing according to Ainamo and Bay1975
gingival index
gingival index measured according to Loe and Silness 1963

Full Information

First Posted
August 4, 2021
Last Updated
September 10, 2021
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05001919
Brief Title
Concentrated Growth Factors in Treatment of Intrabony Defects in Localized Aggressive Periodontitis
Acronym
RCT
Official Title
Concentrated Growth Factors Membrane in the Treatment of Intrabony Periodontal Defects in Localized Aggressive Periodontitis. A Randomized Controlled Split-Mouth Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

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

5. Study Description

Brief Summary
A total of 20 intra-bony defects in 10 LAP patients were randomly assigned into two groups 10 defects each in a split-mouth design. Group I treated by surgery plus Bio-Oss bone graft + collagen membrane (Control group). Group II, treated by surgery plus Bio-Oss bone graft + CGF membrane (Test group). Gingival index (GI), bleeding on probing (BOP), probing pocket depth and clinical attachment level (CAL) were assessed at baseline, 3, 6, and 12 months. Cone beam radiograph evaluation was taken at baseline, and 12 months after surgery..
Detailed Description
Full mouth scaling and root planing was done for all patients followed by Augmentin I gm and metronidazole 500 mg twice daily for 7 days. Additionally, Comprehensive oral hygiene instructions were given to the patients. Sites grouping Four weeks following phase I therapy, the twenty defect sites were randomly classified by sealed envelopes into two groups ten each by a masked supervisor as follows: Group I (10 sites) received surgery + Bio-oss bone graft (Geistlich Pharma AG, Wolhusen, Switzerland) + collagen membrane (control group). Group II (10 sites) received surgery + Bio-oss bone graft +concentrated growth factors membrane (tested group). After the administration of local anesthesia (Xylocaine 2% Adrenaline 1:80,000, ICPA, India), buccal and lingual sulcular incisions were made, and mucoperiosteal flaps were elevated. Thorough debridement of the defects was achieved with hand instruments. The surgical area was irrigated with copious amounts of sterile saline. Bio-oss granules were placed into the defects and the CGFs membrane was trimmed and adapted over the entire defect to cover 2-3 mm of the surrounding alveolar bone and to ensure the stability of the wound and the graft material. For control sites, Bio-oss grafts and a bioresorbable collagen membrane were trimmed and adjusted over the defect in such a way that the whole defect and 2-3 mm of the surrounding alveolar bone were completely covered. Then the flap was repositioned to achieve complete interproximal closure. The flap was then sutured with 4-0 absorbable sutures with single interrupted sutures. A periodontal pack was applied over the surgical area for 10 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aggressive Periodontitis
Keywords
aggressive periodontitis, intrabony defect,, concentrated growth factors membrane

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Twenty intra-bony defects in 10 patients were randomly assigned to either test or control group in split-mouth technique (10 sites in each group).
Masking
ParticipantOutcomes Assessor
Masking Description
Investigator Malak. Shoukheba screened the patients and randomly assigned them to test and control groups and performed the treatment procedures for all participants. Investigator Ahmed. Bader recorded the clinical parameters and she was masked to the randomization for the extent of the study.
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
collagen membrane
Arm Type
Placebo Comparator
Arm Description
10 sites treated with surgery and bone graft and collagen membrane as GTR
Arm Title
Concentrated growth factor membrane
Arm Type
Experimental
Arm Description
10 sites treated by surgery +bone graft and concentrated growth factor membrane as GTR
Intervention Type
Procedure
Intervention Name(s)
GTR
Other Intervention Name(s)
regenerative surgery
Intervention Description
intrabony defects treated by surgery and bone graft +collagen membrane
Intervention Type
Procedure
Intervention Name(s)
concentrated growth factor
Other Intervention Name(s)
regenerative surgery
Intervention Description
intrabony defects treated by surgery and bone graft +concenrated growth factor membrane
Primary Outcome Measure Information:
Title
probing pocket depth
Description
measured from the gingival margin to the base of the pocket using periodontal probe in mm
Time Frame
12 months
Title
clinical attachment level
Description
measured from the cemento-enamel junction to the base of the pocket using periodontal probe in mm
Time Frame
12months
Title
radiographic defect area by cone beam x ray
Description
measured in square millimeter from cone beam x ray
Time Frame
12 months
Title
radiographic bone density by cone beam
Description
By Hounsfield unit from the cone beam x ray
Time Frame
12 months
Secondary Outcome Measure Information:
Title
bleeding on probing
Description
bleeding on probing according to Ainamo and Bay1975
Time Frame
12 months
Title
gingival index
Description
gingival index measured according to Loe and Silness 1963
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Presence of angular periodontal intra-bony defects with clinical attachment loss ≥5 mm measured from CEJ to the deepest propping depth with no evidence of gingival recession optimal compliance as evidenced by no missed treatment appointment and high attitude towards oral hygiene Exclusion Criteria: Patients with relevant medical conditions that may affect periodontal regeneration and surgery smokers, pregnant or lactating women those whom periodontal surgery had previously been carried out on the selected site, and patients who taking any drug known to affect the number or function of platelets
Facility Information:
Facility Name
Malak Yousef Mohamed Shoukheba
City
Tanta
ZIP/Postal Code
20
Country
Egypt

12. IPD Sharing Statement

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Concentrated Growth Factors in Treatment of Intrabony Defects in Localized Aggressive Periodontitis

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