Efficacy of Photodynamic Therapy and LASER Disinfection in Periodontal Therapy for Treatment of Periodontitis

Not Applicable

Recruiting

• Conditions: Periodontitis

• Registration Number: NCT06305533
• Lead Sponsor: University of Baghdad

Brief Summary

The goal of this clinical trial is to Investigate the clinical and microbiological efficacies of Laser disinfection and ICG-mediated aPDT as adjunct to RSD for patients with periodontitis. The main question it aims to answer is:

Does the use of laser disinfection or ICG-mediated aPDT as adjunct to RSD are effective in improving clinical parameters and reducing the load of periodontal pathogens.

Participants will undergo full-mouth supragingival debridement by using ultrasonic device at baseline.

All patients will be instructed to brush their teeth twice daily and will be supplied with the same type of tooth paste and toothbrush, with suitable interdental aids.

All the patients will be instructed to attend again after 7 days. One week later, sites randomly allocated to control (Ctrl) group and test groups which will receive, in addition to RSD, either aPDT or periodontal pocket disinfection (Biolase). For all groups, sites with initial PPD 4-6 mm will be treated with RSD using area specific (Graecy) curettes.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-03-01
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-09
• Last Update Submitted: 2024-03-09
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-09
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Adult subjects (>18 years), non-smoker, with no history of any systemic disease such as diabetes mellitus. Additionally, subjects are not currently under active periodontal therapy or joining other trial in the last 3 months. All patients must be diagnosed with generalized periodontitis with at least 3 teeth in three different sextants (Anterior teeth and premolars) with 4-6 mm PPD and positive BOP. Periodontitis cases will be defined by presence of interdental CAL affecting ≥2 non adjacent teeth or if CAL at buccal/lingual aspects associated with PPD >4mm at ≥2 teeth.

Exclusion Criteria

• Patients will be excluded if they were not diagnosed with periodontitis, smokers, those consuming antibiotics, regular user of nonsteroidal anti-inflammatory drugs, or receiving periodontal treatment 3-months prior to the study. Additionally, pregnant or mothers in a breastfeeding period, and those not willing to participate will be also excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Probing Pocket Depth (PPD)	over a period of 3 months.	PPD will be measured from the gingival margin to the base of the pocket using UNC-15 periodontal probe and the measurements in millimetre .

Secondary Outcome Measures

Name	Time	Method
Bleeding on probing (BOP)	over a period of 3 months.	The BOP will be scored as 0 (absent) and 1 (present) after probing within 30s by quadrant using UNC-15 periodontal probe .
Plaque index (PI)	over a period of 3 months.	Biofilm will be determined using a dichotomous scoring system as presence (1) or absence (0). Disclosing solution will be used to assess agreement on scoring of biofilm.
Clinical attachment loss (CAL)	over a period of 3 months.	CAL will be measured from the cementoenamel junction to the base of the pocket using UNC-15 periodontal probe and the measurements in millimetre .
Change in bacterial load of F. nucleatum and Fretibacterium fastidiosum	over a period of 3 months.	Real time PCR will be used to assess the detection of the following periodontal pathogens in the subgingival biofilm samples: F. nucleatum and F. fastidiosum, according to manufacturer's instructions. Identification of target bacteria through PCR will be executed using species specific primers.

Trial Locations

Locations (1)

College of Dentistry, University of Baghdad; 🇮🇶 Baghdad, Iraq