Evaluation of Antimicrobial Photodynamic Therapy as an Adjunct to Periodontal Treatment in Smokers

NCT03039244 | Completed DMC

• 1 other identifier: 36933014.4.0000.5419
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The study proposes to assess the effect of multiple applications of antimicrobial Photodynamic Therapy (aPDT) as an adjunct to non-surgical periodontal treatment (nsPT) in smokers without use of antibiotics. Twenty smokers with a clinical diagnosis of chronic periodontitis will be treated in a split-mouth design study to either aPDT associated with scaling and root planing (SRP) or SRP only. aPDT will be performed by using a laser light source with 690 nm wavelength associated with a phenothiazine photosensitizer. The applications will occur in four episodes (at days 0, 2, 7 and 14). All patients will be monitored for 90 days. Plaque index, probing depth, clinical attachment level and bleeding on probing will be performed at baseline (pre-intervention period) and 30 and 90 days after the (nsPT). Subgingival plaque samples will be collected (at baseline and 30 and 90 days after the nsPT) and the counts of 40 subgingival species will be determined using DNA-DNA checkerboard hybridization. Gingival crevicular fluid samples will be collected (at Day 0, 14, 30 and 90 after the nsPT) and the levels of Interleukin 1 beta, Interleukin 10 and Tumor Necrosis Factor alpha (Luminex) will be evaluated. Salivary cotinine levels will also be evaluated at baseline. Data obtained will be statistically analyzed.

Conditions

Chronic Periodontitis

Keywords

Photochemotherapy; Photosensitizing agents; Smokers

Outcome Measures

Primary Outcomes (1)

• Clinical Parameter

  clinical attachment level of the selected periodontal sites

  2 years

Secondary Outcomes (4)

• Immunologic Analysis of the selected periodontal sites

  3 years

• Microbiological Analysis of the selected periodontal sites

  3 years

• Salivary Cotinine analysis

  3 years

• Clinical Parameter 2

  2 years

Study Arms (2)

Test Group

EXPERIMENTAL

After Scaling and root planing, periodontal pockets will receive the antimicrobial (aPDT) photodynamic therapy. Shortly phenothiazine hydrochloride photosensitizing is applied at a concentration of 10mg/mL from the pocket bottom to the gingival margin. After 1 minute, irrigation is performed from periodontal pockets with distilled water to remove excess dye. The stained area is then irradiated with a diode laser with 660 nm of wavelength and maximum power of 60 mW/cm², through a fiber-optic probe of 0.6 mm diameter. Exposure to radiation will occur at six sites per tooth under treatment, making the total time of 1 minute per element, or the equivalent of 10 seconds per site. The aPDT applications will be repeated in the same way until the second week in the days 2, 7 and 14.

Other: Photodynamic therapy; Device: Diode Laser

Control Group

SHAM COMPARATOR

A sham procedure will be held simultaneously in pairs of contralateral teeth selected that will not receive the aPDT (control group).

Other: Control Group

Interventions

Photodynamic therapy OTHER

After Scaling and root planing, periodontal pockets will receive the antimicrobial (aPDT) photodynamic therapy. Shortly phenothiazine hydrochloride photosensitizing is applied at a concentration of 10mg/mL from the pocket bottom to the gingival margin. After 1 minute, irrigation is performed from periodontal pockets with distilled water to remove excess dye. The stained area is then irradiated with a diode laser with 660 nm of wavelength and maximum power of 60 mW/cm², through a fiber-optic probe of 0.6 mm diameter. Exposure to radiation will occur at six sites per tooth under treatment, making the total time of 1 minute per element, or the equivalent of 10 seconds per site. The aPDT applications will be repeated in the same way until the second week in the days 2, 7 and 14.

Also known as: Laser therapy

Test Group

Control Group OTHER

A sham procedure will be held simultaneously in pairs of contralateral teeth selected that will not receive the aPDT (control group).

Also known as: Sham procedure

Control Group

Diode Laser DEVICE

Test Group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• diagnosis of chronic periodontitis according to the international classification of periodontal diseases adopted by the American Academy of Periodontology (Armitage, 1999)
• periodontal pockets ≥ 5 mm
• smoking ≥ 20 cigarettes per day

You may not qualify if:

• Positive history of antibiotic therapy in the last six months
• Positive history of basic periodontal treatment in the last six months
• Involvement systemic that might interfere in disease progression or treatment response (eg .: diabetes, immune disorders)
• Pregnant
• Patients with extensive prosthetic wrap
• Patients with the need for antibiotic prophylaxis for performing routine dental procedures

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Mariana Sales

Ribeirão Preto, São Paulo, 14025710, Brazil

Location

Related Publications (1)

• de Melo Soares MS, D'Almeida Borges C, de Mendonca Invernici M, Frantz FG, de Figueiredo LC, de Souza SLS, Taba M Jr, Messora MR, Novaes AB Jr. Antimicrobial photodynamic therapy as adjunct to non-surgical periodontal treatment in smokers: a randomized clinical trial. Clin Oral Investig. 2019 Aug;23(8):3173-3182. doi: 10.1007/s00784-018-2740-3. Epub 2018 Nov 3.

  PMID: 30392080 DERIVED

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Photochemotherapy; Laser Therapy; Control Groups; Lasers, Semiconductor

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Ablation Techniques; Surgical Procedures, Operative; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A random number table will be generated by a computer program, each of the selected pairs dental receive the following treatments: SRP or SRP + several aPDT episodes. The clinical, immunological and microbiological parameters will be evaluated at baseline (pre-intervention) and after the completion of non-surgical periodontal therapy. The periodontal clinical examinations (pre and post-intervention) will be performed by a single trained and calibrated examiner, who unknown the experimental groups of this study. Examiners are also blind to study the immunological and microbiological analyzes. SRP procedures and use of the aPDT protocol should be performed by other trained operator for these purposes.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-Director of School of Dentistry of Ribeirão Preto, University of São Paulo, Brazil

Model Details: The study type will be split mouth with two pairs of contralateral uni-root teeth with proximal periodontal sites presenting probing depth ≥ 5 mm for the clinical, microbiological and immunological assessment. A random number table will be generated by a computer program, each of the selected pairs dental receive the following treatments: SRP or SRP + several aPDT episodes

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: February 1, 2017
• Study Start: September 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: September 1, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

BR (1)