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Clinical Trials/CTRI/2025/11/097897
CTRI/2025/11/097897Not yet recruitingPhase 3

Comparative evaluation of scaling and root planing with and without 980nm diode laser assisted new attachment procedure in Stage II Grade B periodontitis among tobacco chewers A Randomized controlled trial

Dr Impana H A1 site in 1 country8 target enrollmentStarted: December 6, 2025
Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
8
Locations
1
Primary Endpoint
To compare the outcomes of SRP alone versus SRP combined with LANAP in tobacco-chewing patients.

Study Overview

Brief Summary

Periodontal disease forms a major part of the worldwide oral health burden and is closely linked with risk factors that are also associated with many chronic systemic conditions. Periodontitis ranks among the most prevalent dental diseases, resulting in progressive damage to the tooth-supporting and surrounding tissues. The term "periodontitis" is build up of two words, i.e., "periodont-" meaning "structure surrounding the teeth" and "itis" means "inflammation." Periodontitis begins as an inflammatory condition confined to the gingiva, but when left unmanaged, the process extends into the deeper periodontal structures, disrupts bone balance, and may ultimately lead to tooth loss. Periodontal disease has a multifactorial origin. The course of the disease is largely influenced by the host immune response; however, local irritants such as plaque and calculus, genetic predisposition, systemic health status, environmental exposures, lifestyle practices, and broader social determinants also contribute to its progression.

Tobacco chewing—which includes smokeless products such as gutkha, betel quid with tobacco, and other forms—is linked to significant systemic health risks, even beyond oral pathology. A recent meta-analysis found that individuals who chew tobacco face elevated risks of head and neck cancers, including cancers of the lip and oral cavity, as well as esophageal and pharyngeal cancers. The deleterious effects of tobacco chewing on the periodontium are well established. Clinical investigations consistently report deeper periodontal pockets, greater attachment loss, and increased gingival recession in tobacco chewers compared with non-users .

the inclusion of tobacco chewers in the study allows for the exploration of whether laser-assisted therapy can counteract the detrimental effects of tobacco use on periodontal tissues. This study could also provide insights into patient-reported outcomes, including comfort and satisfaction with laser-assisted treatment, which are important considerations in clinical practice.

The findings from this research have the potential to contribute significantly to evidence-based periodontal therapy. If laser-assisted therapy is shown to be effective in tobacco chewers, it could lead to the development of tailored treatment protocols, improving outcomes for a population with historically poor responses to conventional therapies. Furthermore, this study may help bridge the existing gap in literature regarding the role of lasers in high-risk populations, thereby advancing periodontal clinical practice.

This study is needed to evaluate the adjunctive use of a 980 nm diode laser with SRP in the treatment of stage II grade B periodontitis among tobacco chewers. The results will provide high-quality evidence regarding its efficacy, inform clinical decision-making, and potentially improve outcomes for patients who face unique challenges in achieving periodontal health.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
30.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.Patients aged 30 to 60 years systemically healthy 2.Patients diagnosed with Stage II Grade B periodontitis with PPD 5 mm CAL 3 mm 3.Patients who are tobacco chewers especially chewing smokeless tobacco for 5 years.
  • 4.Patients with at least 20 natural teeth.
  • 5.No prior scaling root planning or laser therapy in the last 6 months and willing to complete treatment.
  • 6.Patients willing to comply with study procedures and follow up visits.

Exclusion Criteria

  • 1.Patients with systemic conditions affecting periodontal health .
  • 2.Patients on medications known to affect periodontal healing .
  • 3.Presence of Stage III or IV periodontitis 4.Patients who have received periodontal treatment within the last 6 months.
  • 5.Patients with active orthodontic treatment or patients with a history of substance abuse 6.Patients with a history of laser treatment in the oral cavity.

Outcomes

Primary Outcomes

To compare the outcomes of SRP alone versus SRP combined with LANAP in tobacco-chewing patients.

Time Frame: baseline and after 1 month, 3 months

Secondary Outcomes

  • • To measure clinical periodontal parameters like probing depth, clinical attachment level, bleeding on probing before and after treatment.(baseline and after 1 month, 3 months)

Investigators

Sponsor
Dr Impana H A
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

DrImpanaHA

KVG Dental College and Hospital

Study Sites (1)

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