Adjunct Photodynamic Therapy in Chronic Periodontitis Among Cigarette-smokers.

NCT03308019 | Completed

• 1 other identifier: FR-17-87
• Study Type: interventional
• Target: 83
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Periodontitis; Smoking

Outcome Measures

Primary Outcomes (2)

• Probing depth

  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)

  3 months

• Clinical attachment level gain

  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.

  3 months

Secondary Outcomes (2)

• Plaque index

  3 months

• Bleeding on probing

  3 months

Study Arms (2)

Adjunctive photodynamic therapy

EXPERIMENTAL

This arm will be given scaling and root planing (SRP) with adjunctive photodynamic therapy (aPDT)

Device: Photodynamic therapy; Procedure: Scaling and root planing (SRP)

Dental scaling

ACTIVE COMPARATOR

This arm will be given scaling and root planing (SRP) only

Device: Photodynamic therapy; Procedure: Scaling and root planing (SRP)

Interventions

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.

Adjunctive photodynamic therapy; Dental scaling

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.

Adjunctive photodynamic therapy; Dental scaling

Eligibility Criteria

• Age: 42 Years - 52 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Saud University: lead

MeSH Terms

Conditions

Chronic Periodontitis; Smoking

Interventions

Photochemotherapy; Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Research

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 12, 2017
• Study Start: February 16, 2016
• Primary Completion: July 2, 2017
• Study Completion: September 16, 2017
• Last Updated: October 12, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data is available