INTRODUCTION

Periodontitis is a chronic immuno-inflammatory disease affecting structures surrounding the teeth which is primarily caused by microbiome and the host interplay in response to them.¹ Pathogenic plaque micro flora, host immune responses along with environmental factors play a significant role in the pathogenesis of periodontal pocketformation. Elimination or modification of these contributing factors forms the basis of periodontal treatment.

Complete mechanical plaque removal is the cornerstone of the periodontal treatment. However complete removal of pathologically diseased tissues is impossible owing to nature of periodontal tissues. Hence many adjunctive procedures using local drug delivery, host modulation, chemical plaque control agents have beenevaluated for enhancing the treatment outcomes of periodontitis with varying degrees of success till date. However,the predictability of these treatments is unclear as well as certain antimicrobial agents when used systemically may lead to the development of antimicrobial resistance.

The use of LASER results in reduced post-operative inflammation in addition to being pain free and locallyhaemostatic during treatment. Clinical studies have supported the antibacterial effect of LASERs in treatment of periodontal pockets including tissue regeneration confirmed with histological evidence following LASERmediated Periodontal therapy utilizing the â€œLASER Assisted New Attachment Procedureâ€.² Furthermore, numerous studies have reported that the attenuated LASER at low energy level might stimulate the cells of surrounding tissueresulting in reduction of the inflammatory condition³, in cell proliferation⁴ and in improving the periodontal tissueattachment and potentially reducing postoperative pain.

Diode LASER has a wavelength ranging from 810 nm or 910-980 nm, which does not affect dental hard tissues at this wavelength. Soft tissue Diode LASER has been employed in pocket therapy in various modes with conflicting results in various studies. It is due to non-standardisation of technique used, non-randomisation ofclinical trials, heterogeneity of results and selective reporting of outcomes. There exists a research gap whether soft tissue Diode LASER can be a suitable alternative/adjunct in management of periodontitis. The available strength of evidence on the same is low. The rationale of the proposed study is to evaluate the effectiveness of soft tissue Diode LASER when used as an adjunct to Open Flap Debridement in comparison to Open Flap Debridement alone.

REVIEW OF LITERATURE

Moritz A, Schoop U, Goharkhay K, Schauer P, Doertbudak O(1998) concluded after the analysis of the results obtained, that in addition to scaling, the diode laser exhibits a bactericidal action aiding in reducing inflammation inthe periodontal pockets. By removing bacteria, the diode laser therapy helps to repair the periodontal pockets whenused in conjunction with scaling.⁵

Aoki A, Katia Sasaki KM, Watanabe H, Ishikawa I (2004) did an assessment of laser application in nonsurgical therapy for the management of periodontal diseases. Based on its numerous properties including hemostasis, sterilization and ablation or vaporization, laser therapy may be used in addition to or instead of traditional mechanical periodontal therapy.⁶

Cobb CM (2006) analyzed the use of lasers to treat chronic periodontitis, root surface detoxification and common oral soft tissue issues. Considering clinical attachment level (CAL) as the gold standard for non-surgical periodontaltherapy, the evidence supporting laser-mediated periodontal treatment over traditional therapy is minimal. He concluded that there is limited evidence that lasers used in an adjunctive manner to SRP may provide some additional benefits.⁷

Gaspirc B, Skaleric U (2007) In this study the long-term clinical results of conventional treatment using the modifiedWidman flap procedure and Er:YAG LASER-assisted periodontal flap surgery were compared and analysed. The study included 25 individuals and 146 single-rooted periodontally affected teeth. They came to the conclusion that compared to traditional Widman flap surgery, surgical treatment of single- rooted teeth with chronic periodontitis with the Er:YAG laser producing better PPD reduction and increased CAL up to 3 years.⁸

Gokhale SR, Padhye AM, Byakod G, Jain SA, Padbidri V et al (2012) in their study assessed the effectiveness of using a diode laser in conjunction with mechanical debridement during periodontal flap surgery using clinical and microbiological data. A total of 30 patients with generalized chronic periodontitis with PPD > 5mm after phase Itherapy were included in the study. Diode laser was used as an adjunct to open flap debridement (test) as comparedwith conventional flap surgery (control) in a split-mouth study design. It was concluded from the study that the bactericidal effect of the diode laser was clearly evident by greater reduction of CFU of obligate anaerobes in the testgroup than in the control group.⁹

Zare D, Haerian A, Molla R, Vaziri1 F (2014) compared SRP with the diode laser (980 nm) in terms of reduction in gingival inflammation when utilized between the first and second phases of periodontal treatment. In this study, 21 patients with moderate to severe chronic periodontitis were chosen and split into control and test groups (SRP alone and SRP plus laser). Indexes such as GI, BOP and modified gingival index (MGI) were recorded and compared with baseline, two months after the final scaling and laser treatment. In both groups, all indices improved two months after the study started. With the exception of BOP which was lower in the laser group, the indices did not differ between the two groups. They concluded that the use of laser as an adjunctive treatment in conjunction with conventional methods is preferable based on overall improvements in parameters in addition to lack of thermal damage and gingival recession with the specific settings used in the study.¹⁰

Lobo TM, Pol DG (2015) this study investigated the adjunctive effects of diode laser irradiation during open flap debridement (OFD) to treat chronic periodontitis. They concluded that with the benefit of reduced gingival inflammation, the diode laser can be employed as an adjunct to SRP in treatment of chronic periodontitis.¹¹

Jose KA, Ambooken M, Mathew JJ, Issac AV, Kunju AKP (2016) assessed the effectiveness of adding a diode laser and chlorhexidine chip (CHX) to SRP on clinical parameters such CAL, PPD, PI and GI. This study comprised 15 individuals with chronic periodontitis who had at least one interproximal site with a PPD 5 mm to 7 mm in eachquadrant. They concluded that when CHX chip is used as supplement to SRP in non-surgical periodontal therapy of patients with chronic periodontitis, CHX local delivery alone or in combination with diode laser irradiation is effective in reducing PPD and improving CAL.¹²

Yadwad KJ, Veena HR, Patil SR, Shivaprasad BM (2017) evaluated the effect of 980-nm diode laser, as an adjunct to SRP in the management of chronic periodontitis. They concluded that a 980-nm diode LASER may be a useful adjunct in non-surgical therapy for advanced periodontitis with difficult-to-access subgingival niches whencomprehensive periodontal treatment may not be possible.¹³

MATERIAL AND METHODS

Research gap:- Soft tissue Diode LASER has been employed in pocket therapy in various modes with conflictingresults in various studies. It is due to non- standardization of technique used, non-randomization of clinical trials, heterogeneity of results and selective reporting of outcomes. There exists a research gap whether soft tissue DiodeLASER can be a suitable adjunct in management of periodontitis and the available strength of evidence on the same is also low.

Null hypothesis: - Soft tissue Diode LASER has no significant effect when used as

Alternate hypothesis:- Soft tissue Diode LASER might possess some effects when it is combined with Open Flap Debridement in the management of periodontitis.

Study design: - Randomized Controlled Clinical Trial-Split Mouth Design- Single Blinded Study

Sample size:

Test Group (Group A):- Quadrants receiving Open Flap Debridement with adjunctive use of Soft tissue DiodeLASER for removing pocket lining in the inner aspect of Kirkland flap.

Control Group (Group B):- Quadrants receiving open flap debridement alone using Kirkland flap.

Inclusion criteria:-

2) Patients requiring open flap debridement in atleast two quadrants across the midline.

Exclusion criteria: -

1) Patients with a history of systemic/local antibiotic therapy within 6 months.

5) Patients with plaque and bleeding scores â‰¥ 20% at 4 weeks after phase I therapy.

Method of generating random sequence:- Prior to the surgery, the patient will be

Method of concealment:- The control group will be concealed by Sham treatment using LASER tip in inactive mode.

Blinding/Masking:- All the participants of this trial blinded hence single blinded study.

Primary Outcomes:-

Pocket probing depth (PPD), Clinical attachment level (CAL), Plaque and Bleeding scores.

Secondary Outcomes:-

Methodology:-

The proposed study will be prospectively registered with Clinical Trials Registry of India (CTRI) after Institutional Ethical Committee clearance. Thirty five patients with confirmed diagnosis of Stage II Grade B Generalised Periodontitis will be enrolled from the Department of Periodontology, Army Dental Centre (Research & Referral) will be selected using simple random sampling method without replacement based on inclusion and exclusion criteria. A written informed consent in bilingual form will be obtained from each patient before commencing the procedures involved. Baseline periodontal charting will be done by 3^rd generation automated pressure sensitive probe- Florida probe systemand Phase I therapy will be performed by a single operator which will include scaling & root planing using combination of hand and ultrasonic instruments.

The patients will be re-evaluated after four weeks of Phase I therapy. The patients will be subjected to full mouthperiodontal charting using Florida Probe system. The parameters that will be recorded includes pocket probing depth(PPD), Clinical attachment level (CAL), plaque and bleeding scores. The selected patients will then be randomlyallotted to two different groups.

All the quadrants will be operated with Kirkland flap and will receive active lasing using Soft tissue DiodeLASER having wavelength of 810/980nm and a tip diameter of 200 ðœ‡ï¿½â€™ï¿½. Lasing will be used in continuous wave modewith laser tip in contact mode with soft tissue. Power of 0.5 watt will be used and tissues will be irrigated with normal saline intermittently.

The control sites will be receiving similar flap surgery and Sham treatment using Diode LASER in inactive will be used on inner aspect of flap. The Numerical rating scale (NRS) will be used by a trained operator to assess post operativepain on 3^rd day & 7^th day post operatively after each treatment. The duration between alteration of treatment will be 2weeks. After completion of necessary surgical procedures all the patients will be prescribed similar analgesics and the duration/dose required to manage post operative pain using numbers needed to treat will be noted on 3^rd post operative day and based on the NRS the patients will be prescribed any further analgesics, which will also be recorded. Theperiodontal charting using Florida probe system will further be recorded at 3 and 6 months post operatively. After collection of the data, appropriate descriptive and inferential statistics will be used for the analysis of the proposed study.