Comparative Evaluation of Effect of NSPT With & Without Adjunctive LANAP on OHRQoL: A Randomized Clinical Trial.

NCT07798765 | Completed

• 1 other identifier: NSPT with or without LANAP
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study compared SRP alone and SRP combined with LANAP in 120 patients with chronic periodontitis. Clinical outcomes and oral health-related quality of life (OHRQoL) were assessed before and 12 weeks after treatment. The study aimed to determine how these treatments affect both periodontal health and patients' quality of life.

Conditions

Periodontal Diseases

Keywords

LANAP; LASER; OHRQoL; periodontal disease

Outcome Measures

Primary Outcomes (4)

• gingival index

  Gingival index scores each site on a 0 to 3 scale, with 0 being normal and 3 being severe inflammation. Clinical examination was performed on the six index teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. The scores from the four areas of the tooth were added and divided by four in order to give the GI for the tooth. Finally, by adding the scores for the teeth and dividing by the number of teeth examined, the GI for the individual was obtained

  From enrollment to the end of treatment at 12 weeks

• plaque index

  Plaque index was calculated as the percentage of teeth with visible plaque on any surface of the tooth. For this, clinical examination was performed on the six index teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. The scores from the four areas of the tooth were added and divided by four in order to give the plaque index for the tooth. Plaque index for the individual was obtained by adding the scores for the teeth and dividing by the number of teeth examined

  From enrollment to the end of treatment at 12 weeks

• periodontal pocket depth

  periodontal pocket depth is the distance between the base of the pocket and gingival margin, measured with a periodontal probe (UNC-15) inserted parallel to the vertical axis of tooth. The measurements were made at four sites per tooth \[mesial, buccal, distal and palatal/lingual\] for all teeth, excluding third molar.

  From enrollment to the end of treatment at 12 weeks

• clinical attachment level

  clinical attachment level is the distance between the base of the pocket and a fixed point on crown such as cementoenamel junction. This was assessed using UNC-15 probe from the cementoenamel junction to the base of the pocket at 4 sites \[mesial, buccal, distal and palatal/lingual\].

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (1)

• OHIP 14

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

scaling and root planning only

ACTIVE COMPARATOR

participants in comparator group only received scaling and root planning treatment

Procedure: Scaling and root planing plus placebo

scaling and root planning along with laser assisted new attachment procedure

EXPERIMENTAL

test group received scaling and root planning along with laser assisted new attachment procedure

Procedure: SRP with laser assisted new attachment procedure

Interventions

SRP with laser assisted new attachment procedure PROCEDURE

SRP with laser assisted new attachment procedure along with implementation of OHIP 14 to assess oral health related quality of life

Also known as: SRP + LANAP

scaling and root planning along with laser assisted new attachment procedure

Scaling and root planing plus placebo PROCEDURE

participants received scaling and root planning with implementation of OHIP 14

Also known as: SRP

scaling and root planning only

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with at least \>18 teeth.
• Patients with periodontal pocket depth (PPD) ≥4mm or having ≥3mm clinical attachment loss on at least one of the four surfaces examined.
• Patients with gingival recession defects.
• Patients without occlusal problems or who have received an occlusal correction.
• Patients with no history of periodontal treatment in the last 12 months.
• Patients who are willing to fill out a questionnaire before and after NSPT.

You may not qualify if:

• Patients with cognitive disorders were unable to answer or interpret the questions.
• Pregnant or lactating women.
• Patients with systemic diseases, including immunosuppression, cardiovascular disease, diabetes mellitus, and blood disorders.
• Patients who took antibiotics or immunosuppressants within the last 6 months.
• Patients with acute illnesses and/or active intraoral lesions.
• Patient having teeth with grade III mobility.
• Patients who were chronic smokers or alcoholics.
• Patients with gingival enlargement or pseudo pockets.

Sponsors & Collaborators

• Mahe Nigar: lead
• H.P. Government Dental College and Hospital Shimla: collaborator

Study Sites (1)

Department of Periodontics

Shimla, Himachal Pradesh, 171001, India

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Ajay Mahajan, MDS

  HP GDC SHIMLA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Mahenigar, Junior Resident Periodontics

Model Details: This study compared SRP alone with SRP + LANAP in patients with chronic periodontitis.

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 1, 2026
• Study Start: February 13, 2024
• Primary Completion: January 30, 2025
• Study Completion: April 30, 2025
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)