Comparing the study between two blood products to form new bone.

Phase 4

Not yet recruiting

• Conditions: Chronic periodontitis,

• Registration Number: CTRI/2024/01/061186
• Lead Sponsor: Dr Angela Johnson

Brief Summary

Periodontitis is a chronic, inflammatory, non-communicable condition that damages the periodontium in all ways and cannot be reversed. It is a localized inflammatory response caused by bacterial infection of a periodontal pocket associated with subgingival plaque.The early stages of the disease (gingivitis), inflammation is limited to the gingiva, but in periodontitis, it spreads to deeper tissues, causing swelling, bleeding, and poor smell in the gingiva. When the condition progresses, the periodontium’s supporting collagen degenerates, alveolar bone starts to resorb, and gingival epithelium migrates along the tooth’s surface to produce a "periodontal pocket. The course of periodontitis starts with pocket formation induced by bacterial plaque and a subsequent alveolar bone destruction typical of chronic periodontitis. Bone destruction during periodontitis can be of different morphological patterns including horizontal defects and vertical defects. Periodontal defects can be differentiated based on bone resorption patterns into ‘supraosseous’ (‘suprabony’) and ‘infraosseous’ (‘infrabony’). An infrabony defect is the anatomical consequence of the dental plaque’s apical advancement during the course of the disease. Suprabony defects are those in which the base of the pocket is positioned proximal to the alveolar crest. On the other hand, infrabony defects are those in which the base of the pocket is located apically in relation to the bone crest.Such defects, if left untreated, easily promote periodontitis progression and further loss of attachment. There are many surgical procedures have been developed in an effort to treat periodontitis effectively. One of the earliest and most promising techniques is open flap debridement (OFD). Open flap debridement (OFD) has been shown to result in successful treatment of intrabony defects. A high concentration of platelets make up platelet-rich fibrin (PRF), an autologous non- transfusional hemo-component. The dense fibrin matrix contains leukocytes, platelets, and growth factors, and it can be employed as a biomaterial for healing. PDGF-AB (platelet- derived growth factor AB), TGFß-1 (transforming growth factor ß-1), and VEGF are all found in platelets (vascular endothelial growth factor). These growth factors promote angiogenesis, matrix remodelling, and cell proliferation. Concentrated growth factor (CGFs) are a new generation of platelets concentrates, which contain abundant growth factor. CGFs promote periodontal regeneration and is used in the treatment of periodontal intrabony defects. Concentrated growth factor (CGF) is an excellent material for enhancing bone healing and stimulatory effect on angiogenesis and epithelialization. So concentrated growth factor can be used  for the treatment of infrabony defects.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-01-01
• Study Start: 2024-11-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1.Systemically healthy Participants diagnosed with localized or generalized Stage II/III periodontitis within the age group of 18-50 years.
• Participants with at least one tooth with probing depth (PPD) > 5mm and presence of infrabony component (IC) >3mm site after phase I therapy.

Exclusion Criteria

• Pregnant and lactating women 2.
• Medications which interfere with platelet function within last three months and antibiotics taken within 1 month prior to treatment.
• Patients with systemic disease.
• History of Smoking or tobacco consumption.
• Patients with poor oral hygiene or previous lack of cooperation with the maintenance program.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Relative attachment levels	Baseline - on the day of the surgery and at 3 months
2.Probing depth	Baseline - on the day of the surgery and at 3 months
3.Bleeding index	Baseline - on the day of the surgery and at 3 months

Secondary Outcome Measures

Name	Time	Method
1.Radiographic bone level	2.Bone fill %

Trial Locations

Locations (1)

KM Shah dental college and hospital; 🇮🇳 Vadodara, GUJARAT, India

KM Shah dental college and hospital

🇮🇳Vadodara, GUJARAT, India

Dr Angela Johnson

Principal investigator

9702004902

angelajohnson250796@gmail.com