Chitosan Nano-hydroxyapatite Hydrogel in Non-Surgical Treatment of Intrabony Defect

Not Applicable

Completed

• Conditions: Nano-hydroxyapatite Hydrogel; Intrabony Defect; Chitosan
• Interventions: Other: Nano-HAP/Chitosan hydrogel

• Registration Number: NCT06373757
• Lead Sponsor: October 6 University

Brief Summary

The aim of this study was to evaluate the clinical effect of Chitosan with nano-hydroxyapatite hydrogel in the treatment of periodontal intrabony defects.

Detailed Description

Periodontitis is a chronic inflammation of the periodontium that extends beyond the gingiva and involves the destruction of the connective tissue attachment of the teeth.

Treatment modalities of periodontitis includes local drug delivery such as chitosan which is a derivative of the exoskeleton of many arthropods including prawns, lobsters and crabs.

Chitosan has been used in guided bone regeneration, hemostasis of surgical wounds, and coating of dental implants, in reconstruction of temporomandibular joint disc and guided periodontal tissue regeneration. Moreover, chitosan has been used for preventing demineralization.

HA also called hydroxylapatite, is a naturally occurring mineral form of calcium apatite with the formula Ca5(PO4)3(OH). The OH- ion can be replaced by fluoride, and carbonate, producing fluorapatite or chlorapatite. It crystallizes in the hexagonal crystal system.

Study Timeline

• Study Start: 2023-03-01
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-15
• Last Update Submitted: 2024-04-15
• Study First Posted: 2024-04-18
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Age from 25 to 55 years.
• Both sexes.
• Patients with stage II to III periodontitis with probing pocket depths ≥ 5 mm and radiographic evidence showing infrabony defect.

Exclusion Criteria

• Patients received periodontal or antibiotic therapy within the previous 6 months preceding the study.
• Smokers.
• Pregnant and lactating females.
• Patients on medications known to affect bone turnover or with known side effects to chitosan, nano-hydroxyapatite, and collagen membrane.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (nano-HAP/Chitosan hydrogel):	Nano-HAP/Chitosan hydrogel	The periodontal pockets more than or equal 3-5mm were isolated. Chitosan and nano-HAP hydrogel were prepared in the same steps that were mentioned in the methodology and then the prepared gel was applied to the test site of patients with the deepest probing pocket measurement once per week for 3 weeks. Periodontal dressing (Coe-pack) was to secure the hydrogel in place.

Primary Outcome Measures

Name	Time	Method
Gingival index	6 months after treatment	Gingival index (GI) used for the assessment of prevalence and severity of gingivitis. A score from 0 to 3 is given to each area of the tooth.0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation.; It was evaluated for every patient included in the study, 3 and at 6 months after treatment.

Secondary Outcome Measures

Name	Time	Method
Plaque index	6 months after treatment	Plaque index (PI) was used to assess oral hygiene where 0 = no plaque. 1 = separate flecks of plaque at the cervical margin of the tooth. 2 = a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth.; It was evaluated for every patient included in the study, 3 and at 6 months after treatment.
Clinical attachment level	6 months after treatment	Clinical attachment level (CAL) was evaluated for every patient included in the study, 3 and at 6 months after treatment.
Periodontal probing depth	6 months after treatment	Periodontal probing depth (PD) (referred to as pocket depth if periodontal disease is present) is the distance from the gingival margin to the apical portion of the gingival sulcus. Probing depths in healthy gingival sulci normally range from 1 to 3 mm.; It was evaluated for every patient included in the study, 3 and at 6 months after treatment.
Acrylic stent for pocket assessment	6 months after treatment	Acrylic stent for pocket assessment was evaluated for every patient included in the study, 3 and at 6 months after treatment.

Trial Locations

Locations (1)

October 6 University; 🇪🇬 Giza, Egypt