To evaluate effectiveness of oxygen releasing gel as an adjunct to non-surgical periodontal therapy on salivary and serum chemerin and interleukin-6 levels in patients of periodontitis with type 2 diabetes mellitus- A randomized controlled clinical trial

All the patients included in the study will undergo assessment of HbA1c level before starting of any therapy.

Clinical attachment level, probing depth, plaque index, gingival index and sampling site will be evaluated by one examiner.

 Clinical parameters includes

1)Gingival index by Loe H and Silness J (1963)

2. Periodontal pocket Depth by Carranza FA et al. 2013 - The distance from the gingival margin to the bottom of the gingival sulcus. Probing depth will be recorded on 6 sites of each tooth.

3. Clinical attachment level (CAL) by Carranza FA et al. 2013 â€“ It is the distance from stable reference point that is cementoenamel junction (CEJ) to the base of periodontal pocket.

4)Plaque index by Silness J and Loe H 1964

Randomization And Allocation - The patients will be randomized through a computer generated sequence of random numbers and then group allocation concealment will be done by sealed opaque envelope.

GROUP 1 –  20  Patients of periodontitis with type -2 diabetes mellitus who will receive non-surgical periodontal therapy (Scaling and root planing) alone.

GROUP 2 – 20  patients of periodontitis with Type 2 diabetes mellitus who will receive non-surgical periodontal therapy (Scaling and root planing) with application of oxygen releasing gel.

All the procedures will be done by single operator. Random assignment will be used to place patients in one of the therapy groups.

Test group - Patients of periodontitis with type -2 diabetes mellitus who will receive non-surgical periodontal therapy (Scaling and root planing) with application of oxygen releasing gel.

Control group - Patients of periodontitis with type -2 diabetes mellitus who will receive non-surgical periodontal therapy (Scaling and root planing) alone.

At patient’s first visit, saliva and serum will be collected. Unstimulated saliva will be collected and before collection of saliva patient will be instructed to rinse the mouth thoroughly then patient will be guided to sit comfortable and asked to swallow their saliva first and then bend their heads forwardly and allow the saliva to passively drain into a sterile container which will be transferred into eppendrof  tube . For serum analysis venous blood will be collected in a sterile vial without anti-coagulant and will be kept for 1 hour at room temperature to allow blood to clot and after 1 hour serum will be separated by centrifuge.

Both serum and saliva will be stored at -80℃ until immunological analysis of levels of chemerin and interleukin-6 by Enzyme linked immunosorbent assay will be performed. Clinical parameters will also be recorded at same time for baseline measurements.

After baseline measurements all patients will undergo non-surgical periodontal therapy and in patients under test group we will apply oxygen releasing gel at periodontal pocket sites.

Saliva and serum will be collected again for analysis of chemerin and interleukin-6 level by Enzyme linked immunosorbent assay at 8 weeks and 12 weeks. Clinical parameters and will also be recorded after 8 weeks and 12 weeks.

HbA1c will be analysed again at 12 weeks.