NCT07339670

Brief Summary

The aim of this study is to evaluate how smoking affects the healing process of the gums after treatment. The researchers will measure the levels of two specific proteins (PLAP-1 and Sclerostin) in the gum fluid of patients with stage II periodontitis. These measurements will be compared between smokers and non-smokers before and after receiving non-surgical periodontal therapy (cleaning and scaling) to see if smoking changes the body's response to treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2025

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

January 5, 2026

Last Update Submit

January 5, 2026

Conditions

Smoking ( Cigarette)Periodontitis Stage II

Outcome Measures

Primary Outcomes (2)

  • change in periodontal ligament associated protien-1 levels

    Concentration of PLAP-1 measured in Gingival Crevicular Fluid (GCF) using ELISA technique. This protein reflects the status of the periodontal ligament.

    Baseline (before treatment) and 6 months after treatment

  • Change in Sclerostin levels

    Concentration of Sclerostin measured in Gingival Crevicular Fluid (GCF) to evaluate bone remodeling activity.

    Baseline and 6 months after treatment

Secondary Outcomes (5)

  • Change in Probing Pocket Depth

    Baseline , 3 and 6 months after treatment

  • Change in Clinical Attachment Level

    Baseline , 3 and 6 months after treatment

  • Change in Plaque Index (PI).

    Baseline , 3 and 6 months after treatment.

  • Change in Gingival Index (GI).

    Baseline, 3 and 6 months after treatment.

  • Change in Bleeding on Probing (BOP) percentage.

    Baseline, 3 and 6 months after treatment.

Study Arms (2)

smoker with periodontitis

ACTIVE COMPARATOR

patients with stage II periodontitis who are current smoker and will receive non-surgical periodontal therapy

Procedure: Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)

Non-smokers with periodontitis

ACTIVE COMPARATOR

patients with stage II periodontitis who have never smoked and will receive Non-surgical therapy

Procedure: Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)

Interventions

Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)PROCEDURE

scaling , curettage and root planning

Non-smokers with periodontitissmoker with periodontitis

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female aged from 25 - 40 years old.
  • Patients diagnosed as having Stage II periodontitis.
  • Group of current smoker's patients, more than 10 cigarettes per day.
  • Group of non-smoker's patients.
  • Maximum probing depth ≤ 5 mm, mostly horizontal bone loss.
  • Clinical Attachment loss from 3-4 mm.
  • Radiographic bone loss about 15% to 33%, mostly horizontal.

You may not qualify if:

  • Pregnant or lactating women.
  • Any known systemic disease.
  • Patients who received periodontal treatment in last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dental Medicine for Girls, Al-Azhar University

Cairo, Nasr City, 4450113, Egypt

Location

MeSH Terms

Conditions

Cigarette SmokingPeriodontitis

Interventions

ListerineEthanolmethyl salicylateMentholThymol

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco UsePeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsCyclohexanolsHexanolsFatty AlcoholsCyclohexane MonoterpenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsMonoterpenesTerpenesLipidsPhenolsBenzene DerivativesHydrocarbons, Aromatic

Study Officials

  • Manar Morsi Morsi, MSc

    Faculty of Dental Medicine for Girls, Al-Azhar University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dentist

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 14, 2026

Study Start

November 11, 2024

Primary Completion

April 11, 2025

Study Completion

April 30, 2025

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

The individual participant data will not be available to preserve patient confidentiality and because the informed consent signed by participants did not include a provision for public data sharing

Locations

EG(1)