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

NCT05001919 | Completed Phase 1

• 1 other identifier: 5
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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..

Conditions

Aggressive Periodontitis

Keywords

aggressive periodontitis; intrabony defect,; concentrated growth factors membrane

Outcome Measures

Primary Outcomes (4)

• probing pocket depth

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

  12 months

• clinical attachment level

  measured from the cemento-enamel junction to the base of the pocket using periodontal probe in mm

  12months

• radiographic defect area by cone beam x ray

  measured in square millimeter from cone beam x ray

  12 months

• radiographic bone density by cone beam

  By Hounsfield unit from the cone beam x ray

  12 months

Secondary Outcomes (2)

• bleeding on probing

  12 months

• gingival index

  12 months

Study Arms (2)

collagen membrane

PLACEBO COMPARATOR

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

Procedure: GTR

Concentrated growth factor membrane

EXPERIMENTAL

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

Procedure: concentrated growth factor

Interventions

GTR PROCEDURE

intrabony defects treated by surgery and bone graft +collagen membrane

Also known as: regenerative surgery

collagen membrane

concentrated growth factor PROCEDURE

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

Also known as: regenerative surgery

Concentrated growth factor membrane

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Malak Yousef Mohamed Shoukheba

Tanta, 20, Egypt

Location

MeSH Terms

Conditions

Aggressive Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate prof

Model Details: 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).

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 12, 2021
• Study Start: July 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: August 1, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-09

Locations

EG (1)