Skip to main content
Clinical Trials/NCT05001919
NCT05001919CompletedPhase 1

Concentrated Growth Factors Membrane in the Treatment of Intrabony Periodontal Defects in Localized Aggressive Periodontitis. A Randomized Controlled Split-Mouth Clinical Study

Tanta University1 site in 1 country10 target enrollmentStarted: July 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
probing pocket depth

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes 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.

Eligibility Criteria

Ages
20 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

collagen membrane

Placebo Comparator

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

Intervention: GTR (Procedure)

Concentrated growth factor membrane

Experimental

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

Intervention: concentrated growth factor (Procedure)

Outcomes

Primary Outcomes

probing pocket depth

Time Frame: 12 months

measured from the gingival margin to the base of the pocket using periodontal probe in mm

clinical attachment level

Time Frame: 12months

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

Time Frame: 12 months

measured in square millimeter from cone beam x ray

radiographic bone density by cone beam

Time Frame: 12 months

By Hounsfield unit from the cone beam x ray

Secondary Outcomes

  • bleeding on probing(12 months)
  • gingival index(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

malak mohamed shoukheba

associate prof

Tanta University

Study Sites (1)

Loading locations...

Similar Trials