Effect of the Diode Laser on Bacteremia Associated With Periodontal Flap Surgery: A Clinico-Microbiological Study

NCT04207034 | Unknown

• 1 other identifier: 02_D012_91549
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the present study is

1. 1.To study the incidence and magnitude of bacteremia after periodontal flap surgery .
2. 2.To compare and evaluate the effect of diode laser on frequency of bacteremia associated with periodontal flap surgery .
3. 3.To study the incidence of bacteremia after laser therapy

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• Assessment of bacteremia using PCR

  Bacteremia in venous blood before starting the procedure, after 5 minutes and within 30 minutes of the start of the procedure

  After 24 hours of collection

Study Arms (2)

flap surgery and diode laser

EXPERIMENTAL

Patient will be asked to rinse with 0.2% chlorhexidine mouthwash. Following the administration of local anaesthesia 2% lignocaine hydrochloride ( with 1: 80,000 epinephrine) , Laser application will be carried out , with the help of 810 nm (A.R.C LASER FoxTM) diode laser with a flexible optic tip of 300µm . The sulci will be lased with a repeated beam ( 0.2 sec on 0.3 sec off) at an output power of 1.0 W. Intracrevicular incision will be placed with the help of 15c Bard Parker surgical blade , full thickness mucoperiosteal flap will be elevated . Debridement of granulation tissue will be done and flap will be suture back in position using 3-0 black breaded silk suture, the site will be covered with non eugenol periodontal dressing for protection. Postoperative instructions will be given to the patient. 2 ml blood will be collected at baseline(sample 1) , at 5 minutes (sample 2) and within 20-30 minutes (sample 3) of starting the procedure.

Procedure: flap surgery with diode laser

flap surgery

ACTIVE COMPARATOR

Patient will be asked to rinse with 0.2% chlorhexidine mouthwash. Following the administration of local anaesthesia 2% lignocaine hydrochloride ( with 1:80,000 epinephrine) ,intracrevicular incision will be placed with the help of 15c Bard Parker surgical blade , full thickness mucoperiosteal flap will be elevated . Debridement of granulation tissue will be done and flap will be suture back in position using 3-0 black breaded silk suture, the site will be covered with non eugenol periodontal dressing for protection. Postoperative instructions will be given to the patient. 2 ml blood will be collected at baseline(sample 1) , at 5 minutes (sample 2) and within 20-30 minutes (sample 3) of starting the procedure

Procedure: flap surgery

Interventions

flap surgery with diode laser PROCEDURE

Patient will be asked to rinse with 0.2% chlorhexidine mouthwash. Following the administration of local anaesthesia 2% lignocaine hydrochloride ( with 1: 80,000 epinephrine) , Laser application will be carried out , with the help of 810 nm (A.R.C LASER FoxTM) diode laser with a flexible optic tip of 300µm . The sulci will be lased with a repeated beam ( 0.2 sec on 0.3 sec off) at an output power of 1.0 W. Intracrevicular incision will be placed with the help of 15c Bard Parker surgical blade , full thickness mucoperiosteal flap will be elevated . Debridement of granulation tissue will be done and flap will be suture back in position using 3-0 black breaded silk suture, the site will be covered with non eugenol periodontal dressing for protection. Postoperative instructions will be given to the patient. 2 ml blood will be collected at baseline(sample 1) , at 5 minutes (sample 2) and within 20-30 minutes (sample 3) of starting the procedure.

flap surgery and diode laser

flap surgery PROCEDURE

Patient will be asked to rinse with 0.2% chlorhexidine mouthwash. Following the administration of local anaesthesia 2% lignocaine hydrochloride ( with 1:80,000 epinephrine) ,intracrevicular incision will be placed with the help of 15c Bard Parker surgical blade , full thickness mucoperiosteal flap will be elevated . Debridement of granulation tissue will be done and flap will be suture back in position using 3-0 black breaded silk suture, the site will be covered with non eugenol periodontal dressing for protection. Postoperative instructions will be given to the patient. 2 ml blood will be collected at baseline(sample 1) , at 5 minutes (sample 2) and within 20-30 minutes (sample 3) of starting the procedure

flap surgery

Eligibility Criteria

• Age: 30 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patient with age 30 -40 years .
• Systemically healthy patients.
• Patients having probing depth of ≥ 5mm and ≤ 8 mm at minimum of two sites and good level of oral hygiene after initial therapy.
• No signs of gingival inflammation

You may not qualify if:

• Patient with history of smoking, antibiotic therapy within the previous three months.
• Patient with subgingival restorations and use of antiseptic mouthwash.
• Congenital or acquired cardiac defects, cardiac prosthesis.
• Hematological disorder.
• Immunocompromised patients

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

Study Sites (1)

MLV Prabhuji

Bangalore, Karnataka, 562157, India

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

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)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Akanksha Dubey, MDS

  Rajiv Gandhi University of Health Sciences

  PRINCIPAL INVESTIGATOR

• MLV Prabhuji, MDS

  Rajiv Gandhi University of Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double (investigator and outcome Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: proffesor/ Head of the department Periodontology

Model Details: The study was performed according to split- mouth design, and all teeth in the mouth were treated randomly using either the left or the right side of the maxilla and mandible for control , and the opposite side for the therapy. Each patient was entered into a clinical protocol consisting of two different treatment modalities. Group I (n=10) - Test group ( diode laser + flap surgery) Group II (n=10) - control group (flap surgery)

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 20, 2019
• Study Start: January 1, 2020
• Primary Completion: December 30, 2020
• Study Completion: January 10, 2021
• Last Updated: December 17, 2020

Record last verified: 2020-12

Locations

IN (1)