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

Sponsor

Tanta University (Other)

Overall Status

Completed

CT.gov ID

NCT05001919

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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..

Condition or Disease	Intervention/Treatment	Phase
Aggressive Periodontitis	Procedure: GTR Procedure: concentrated growth factor	Phase 1/Phase 2

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

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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).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:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2020

Actual Primary Completion Date :

Jul 1, 2021

Actual Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: collagen membrane 10 sites treated with surgery and bone graft and collagen membrane as GTR	Procedure: GTR intrabony defects treated by surgery and bone graft +collagen membrane Other Names: regenerative surgery
Experimental: Concentrated growth factor membrane 10 sites treated by surgery +bone graft and concentrated growth factor membrane as GTR	Procedure: concentrated growth factor intrabony defects treated by surgery and bone graft +concenrated growth factor membrane Other Names: regenerative surgery

Arm

Intervention/Treatment

Placebo Comparator: collagen membrane

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

Procedure: GTR

intrabony defects treated by surgery and bone graft +collagen membrane

Other Names:

regenerative surgery

Experimental: Concentrated growth factor membrane

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

Procedure: concentrated growth factor

intrabony defects treated by surgery and bone graft +concenrated growth factor membrane

Other Names:

regenerative surgery

Outcome Measures

Primary Outcome Measures

probing pocket depth [12 months]
measured from the gingival margin to the base of the pocket using periodontal probe in mm
clinical attachment level [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 [12 months]
measured in square millimeter from cone beam x ray
radiographic bone density by cone beam [12 months]
By Hounsfield unit from the cone beam x ray

Secondary Outcome Measures

bleeding on probing [12 months]
bleeding on probing according to Ainamo and Bay1975
gingival index [12 months]
gingival index measured according to Loe and Silness 1963

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

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