Comparative evaluation of the clinical and radiographic outcomes of Nanohydroxyapatite bone graft with and without Chitosan Nanohydrogel in periodontal bony defects A randomized clinical trial

Aim: The aim of this present study is to evaluate the efficacy of Chitosan Nanohydrogel along with Nano Hydroxyapatite bone graft compared to Nano Hydroxyapatite bone graft alone, in the treatment of Periodontal Bony Defects.

All the participants will be explained about the aim, nature, and design of the study along with a written informed consent for their participation before the commencement of the study.

The study is planned as a randomized clinical trial conducted in individuals with bilateral periodontal bony defects.

The study duration is 9-12 months in which the radiographic parameters will be recorded at baseline and 6 months and  clinical parameters will be recorded at baseline, 1 and 6 months.

The study will be performed in accordance with the Helsinki Declaration of 1975, as revised in 2013.

The radiographic parameters include:

1. Amount of bone fill.

2. Percentage of bone fill.

The clinical parameters for assessment include:

1)   Periodontal probing depths (PD)

2)  Clinical attachment levels (CAL)

3)      Gingival Bleeding Index (GBI)

All patients included in the study will be evaluated before the treatment procedure and patients with bilateral periodontal bony defects are selected.

Two sites left and right halves of the maxillary and mandibular arches will be selected and assigned as test and control group.

Test group: Open flap debridement with Chitosan Nanohydrogel with Nanohydroxyapatite bone graft placement.

Control group: Open flap debridement with Nanohydroxyapatite bone graft placement.

Procedure: Participants with periodontal disease will be selected from the outpatient Department of Periodontology depending on the inclusion criteria and then thorough scaling and root planning will be done. Participants will be recalled after 4 weeks for re-evaluation of pocket depth. Participants with bilateral bony defects will be chosen. 30 sites from 15 patients will be selected and randomly assigned into test and control sites by computer generated randomization method. The customized acrylic occlusal stent will be prepared, which serves as a guide for standardization during the evaluation of clinical parameters (Periodontal probing depths, clinical attachment levels) . In both test and control sites, under local anesthesia, Kirkland flap will be raised, and thorough debridement will be done followed by placement of CNHG + NHA BG in the bony defect of test site and NHA BG alone in the control site. Then flap will be approximated, and sutures. The bone graft used for this study is commercially available and chitosan Nanohydrogel is prepared in PERIOBIOLOGICS LLP laboratory. Post operative instructions will be given to the participants and will be recalled after 1 week for suture removal. In case of any discomfort participants are advised to report back