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Completed

NCT Number: NCT06373757

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

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

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Key information

Conditions

Chitosan Intrabony Defect Nano-hydroxyapatite Hydrogel

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

October 6 University

Giza, 12511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nano-HAP/Chitosan hydrogel

Other

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 outcomes

  1. Gingival index

    Time frame: 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 outcomes

  1. Plaque index

    Time frame: 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.

  2. Clinical attachment level

    Time frame: 6 months after treatment

    Clinical attachment level (CAL) was evaluated for every patient included in the study, 3 and at 6 months after treatment.

  3. Periodontal probing depth

    Time frame: 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.

  4. Acrylic stent for pocket assessment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Official study title

Chitosan Nano-hydroxyapatite Hydrogel in Non-Surgical Treatment of Intrabony Defect (Randomized Clinical Trial)

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 18, 2024
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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