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Completed

NCT Number: NCT07798765

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

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.

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Key information

Conditions

Periodontal Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Periodontics

Shimla, Himachal Pradesh, 171001, India

About this study

This study examined two non-surgical treatments for chronic periodontitis, a common inflammatory disease that damages the gums and supporting structures of the teeth and may eventually lead to tooth loss. A total of 120 patients aged 18-65 years were randomly assigned to receive either conventional scaling and root planning (SRP) alone or SRP combined with laser-assisted new attachment procedure (LANAP). Clinical indicators of periodontal health, including gum inflammation, plaque accumulation, pocket depth, and attachment loss, were assessed before treatment and after 12 weeks. The study also evaluated patients' perceptions of their oral health and quality of life using the OHIP-14 questionnaire.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Other names: SRP + LANAP

Scaling and root planing plus placebo

Procedure

participants received scaling and root planning with implementation of OHIP 14

Other names: SRP

Primary outcomes

  1. gingival index

    Time frame: From enrollment to the end of treatment at 12 weeks

    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

  2. plaque index

    Time frame: From enrollment to the end of treatment at 12 weeks

    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

  3. periodontal pocket depth

    Time frame: From enrollment to the end of treatment at 12 weeks

    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.

  4. clinical attachment level

    Time frame: From enrollment to the end of treatment at 12 weeks

    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].

Secondary outcomes

  1. OHIP 14

    Time frame: From enrollment to the end of treatment at 12 weeks

    The OHIP-14 questionnaire was administered in its original English version, with a Hindi adaptation provided to facilitate understanding among patients who were not proficient in English. The questionnaire comprises seven dimensions (or domains), each containing two subdomains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Responses were recorded using a Likert scale ranging from 0 to 4, where 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, and 4 = very often.

Sponsors and collaborators

Lead sponsor

Mahe Nigar

Other

Collaborators

  • H.P. Government Dental College and Hospital Shimla

Registry information

Official study title

Comparative Evaluation Of The Impact Of Scaling & Root Planning With & Without Adjunctive Use Of Laser Assisted New Attachment Procedure On Oral Health Related Quality Of Life In Patients With Periodontitis -A Randomized Clinical Trial

Acronym: LANAP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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