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Completed

NCT Number: NCT03308019

Adjunct Photodynamic Therapy in Chronic Periodontitis Among Cigarette-smokers.

This study evaluates the efficacy of scaling and root planing with and without adjunct antimicrobial photodynamic therapy (aPDT) in the treatment of chronic periodontitis (CP) among cigarette-smokers and never-smokers.

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Key information

Conditions

Chronic Periodontitis Behavior Chronic Disease Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Smoking Stomatognathic Diseases

Age range

42 year–52 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

The following inclusion criteria were entailed: (a) Self-reported habitual cigarette-smokers; (b) self-reported never-smokers; (c) patients with CP (presence of at least 30% sites with ≥ 3 mm of CAL and PD ≥ 3 mm 18, 19 ). The exclusion criteria were as follows: (a) patients with systemic diseases such as acquired immune deficiency syndrome/HIV and diabetes mellitus; (b) habitual smokeless tobacco product and alcohol users; (c) third molars and fractured teeth with embedded root remnants and edentulous individuals; (d) patients with misaligned teeth; and (e) patients that reported to have used antibiotics, non-steroidal anti-inflammatory drugs and/or steroids within the past 90 days.

Demographic information was collected using a questionnaire. Cigarette-smokers (group-1) and never-smokers (group-2) with chronic periodontitis were included. Treatment wise, these individuals were divided into two subgroups as follows: (a) SRP alone and (b) SRP with adjunct aPDT. Periodontal parameters (plaque index [PI], bleeding on probing [BOP], clinical attachment loss [CAL] and probing pocket depth ≥4mm [PD] were measured at baseline and at 1 month and 3 months' follow-up.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Self-reported habitual cigarette-smokers.
  • Self-reported never-smokers.
  • Patients with chronic periodontitis (presence of at least 30% sites with ≥ 3 mm of CAL and PD ≥ 3 mm.

Exclusion criteria

  • Patients with systemic diseases such as acquired immune deficiency syndrome/HIV and diabetes mellitus.
  • Habitual smokeless tobacco product and alcohol users.
  • Third molars and fractured teeth with embedded root remnants and edentulous individuals.
  • Patients with misaligned teeth.
  • Patients that reported to have used antibiotics, non-steroidal anti-inflammatory drugs and/or steroids within the past 90 days.

Treatment and study plan

Photodynamic therapy

Device

In groups 1 and 2, aPDT was performed after SRP. The protocol for aPDT is described elsewhere. Briefly, using a blunt needle, 0.005% of Methylene blue was applied into the periodontal pocket and left in place for 10 seconds. The dye was then irradiated with a diode laser (670 nanometers) at 150 milliwatts. In each dye filled periodontal pocket, laser irradiation was performed for one minute using a flexible tip. In the present study, aPDT was performed once, at baseline, by a trained dentist.

Scaling and Root Planing (SRP)

Procedure

In both groups, SRP was performed in one session under local anesthesia using handheld Gracey curettes No. 5/6. One trained dental hygienist blinded to the study groups and subgroups made 9 to 10 strokes in a vertical (apico-coronal) direction and the inclination between scaler tips and roots was maintained as zero. When the curved explorer indicated a smooth and hard dental surface, SRP was judged as completed. In all individuals, SRP was done in one session without any assigned time limit for completion.

Primary outcomes

  1. Probing depth

    Time frame: 3 months

    Probing depth will be measured as the distance from the gingival margin to the location of the tip of the probe to the nearest millimeter. Pocket depth assessment was carried out at 6 sites per tooth for all teeth (disto-buccal, mid-buccal, mesio-buccal, mesio-lingual, mid-lingual and disto-lingual)

  2. Clinical attachment level gain

    Time frame: 3 months

    Clinical attachment level gain will be calculated for each site as the sum of probing depth and gingival recession. The CAL was recorded at 6 sites per tooth for all teeth (disto-buccal, mid-buccal, mesio-buccal, mesio-lingual, mid-lingual and disto-lingual) except third molars.

Secondary outcomes

  1. Plaque index

    Time frame: 3 months

    Plaque index will be detected visually by running the probe at 4 sites per tooth (mesio-buccal, disto-buccal, mid-buccal and palatal/lingual) for absence or presence of plaque, based on dichotomous scoring system. The scores ranged as follows; 0 - No visible plaque

    1 - Visible plaque

  2. Bleeding on probing

    Time frame: 3 months

    Bleeding on probing will be recorded at 4 sites per tooth (mesio-buccal, disto-buccal, mid-buccal, and palatal/lingual) for absence or presence of bleeding, based on dichotomous scoring system. The scores ranged as follows; 0 - No visible bleeding

    1 - Visible bleeding

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Registry information

Official study title

Effectiveness of Scaling and Root Planing With and Without Adjunct Antimicrobial Photodynamic Therapy in the Treatment of Chronic Periodontitis Among Cigarette-smokers and Never-smokers: A Randomized Controlled Clinical Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 12, 2017
Registry last updated
Oct 12, 2017

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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