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

Aggressive Periodontitis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05001919
• Other study ID #: 5
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 1, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: September 2021
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Aggression
• Aggressive Periodontitis
• Periodontitis

Intervention

Procedure:
• GTR
intrabony defects treated by surgery and bone graft +collagen membrane
• concentrated growth factor
intrabony defects treated by surgery and bone graft +concenrated growth factor membrane

Locations

Country	Name	City	State
Egypt	Malak Yousef Mohamed Shoukheba	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	probing pocket depth	measured from the gingival margin to the base of the pocket using periodontal probe in mm	12 months
Primary	clinical attachment level	measured from the cemento-enamel junction to the base of the pocket using periodontal probe in mm	12months
Primary	radiographic defect area by cone beam x ray	measured in square millimeter from cone beam x ray	12 months
Primary	radiographic bone density by cone beam	By Hounsfield unit from the cone beam x ray	12 months
Secondary	bleeding on probing	bleeding on probing according to Ainamo and Bay1975	12 months
Secondary	gingival index	gingival index measured according to Loe and Silness 1963	12 months