EFFECT of USE of DIODE LASER and 3% NaOCl for HEMOSTASIS in DIRECT PULP CAPPING on OUTCOME in MILD and MODERATE PULPITS

NCT06765447 | Completed DMC

• 1 other identifier: Dr. Varsha
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Goal of this prospective clinical study is evaluate the effect of use of diode laser and 3% NaOCl for hemostasis in direct pulp capping on outcome in mild and moderate pulpitis Population includes systemically healthy patient of age 18-45 years with extremely deep carious lesion in mandibular molar with normal periapical structure exibiting symptoms of mild and moderate pulpits .Clinical outcome assessed at 1 week and 3month by using electric pulp testing and cold test radiographic outcome will be assessed using periapical index scoring system at 6 and 12 months follow up period.

Conditions

HEMOSTASIS; DIRECT PULP CAPPING

Outcome Measures

Primary Outcomes (2)

• 1.Clinical success rate

  Clinical criteria of success:- 1.No pain or discomfort except for the first few days after treatment. 2.No tenderness to palpation or percussion and the tooth is functional. 3.Normal mobility and probing pocket depth. 4.Healthy soft tissues around teeth with no swelling, sinus tract.

  [ baseline to 12 months]

• 2.Radiographic success rate

  Radiographic success criteria:- 1.No pathosis such as root resorption, furcal pathosis or new periapical pathosis evident on the radiograph. 2.Complete radiographic healing

  [Time Frame: baseline to 12 months]

Secondary Outcomes (1)

• 3. Post Operative Pain

  [Time Frame: Baseline to 7 days]]

Study Arms (2)

3% NaOCl

ACTIVE COMPARATOR

after pulp exposure bleeding was control by placing a cotton pellet soaked with 3%NaOCl over the pulpal wound upto 1 minutes.If hemostasis was not achieve with in 1mins we again use soaked cotton pellet of 3% NaOCL for another 1 mint until the hemostasis acheived. Tooth with excessive uncontrollable bleeding even after 5 mins was excluded from the study

Procedure: hemostasis with 3% NaOCl in direct pulp capping; Procedure: hemostasis with diode laser in direct pulp capping

diode laser

EXPERIMENTAL

Hemostasis was achieved by exposure to Primo dental diode laser by medency (980 nm), at 0.5 W(medency Primo laser) .During laser application patients, operator and assistant were asked to wear protective eye shields.The laser energy of wavelength 980 nm introduced to the exposure site through a 400 µm optical fiber in a non contact mode for 2-3 seconds at exposure site for three times at 10s time interval to achieve complete hemostasis.For disinfection same diode laser of wavelength 980nm with energy set at 1W used in non contact mode in circular motion in the cavity

Procedure: hemostasis with 3% NaOCl in direct pulp capping; Procedure: hemostasis with diode laser in direct pulp capping

Interventions

hemostasis with 3% NaOCl in direct pulp capping PROCEDURE

after pulp exposure bleeding was control by placing a cotton pellet soaked with 3%NaOCl over the pulpal wound upto 1 minutes.If hemostasis was not achieve with in 1mins we again use soaked cotton pellet of 3% NaOCL for another 1 mint until the hemostasis acheived. Tooth with excessive uncontrollable bleeding even after 5 mins was excluded from the study; however, definite treatment was provided to the patient.The time used to control bleeding was recorded for each tooth by using stop watch.Once hemostasis is achieved, exposed pulp was capped with biodentine.

3% NaOCl; diode laser

hemostasis with diode laser in direct pulp capping PROCEDURE

Hemostasis was achieved by exposure to Primo dental diode laser by medency (980 nm), at 0.5 W(medency Primo laser) .During laser application patients, operator and assistant were asked to wear protective eye shields.The laser energy of wavelength 980 nm introduced to the exposure site through a 400 µm optical fiber in a non contact mode for 2-3 seconds at exposure site for three times at 10s time interval to achieve complete hemostasis.For disinfection same diode laser of wavelength 980nm with energy set at 1W used in non contact mode in circular motion in the cavity .Biodentine was used as pulp capping agent.

3% NaOCl; diode laser

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy patients (ASA I ).2.Patients in the age group of 18-45 years.Unrestored permanent mandibular posterior teeth.3.Extremely deep caries defined as radiographic evidence of caries penetrating the entire thickness of the dentine with certain pulp exposure. In extremely deep lesions, the demineralized process extends the entire thickness of the dentine, which perhaps excludes these cases from selective caries removal and a strategy based on avoiding pulp exposure. (l.bjorndal et al.2019).4.Vital tooth with signs and symptoms of mild and moderate pulpitis .Mild pulpitis Heightened and lengthened reaction to cold, warmth and sweet stimuli that can last up to 20 s but then subsides, possibly percussion sensitive. According to the histological situation that fits these findings, it would be implied that there is limited local inflammation confined to the crown pulp (W. J. Wolters et al.).Moderate pulpitis Clear symptoms, strong, heightened and prolonged reaction to cold, which can last for minutes, possibly percussion sensitive and spontaneous dull pain that can be more or less suppressed with pain medication. According to the histological situation that fits these findings, it would be implied that there is extensive local inflammation confined to the crown pulp.5.Occlusal pulp exposure because of caries removal.6.Exposure size upto 0.5 to 1 mm

You may not qualify if:

• No pulp exposure after caries excavation.2.No bleeding after pulp exposure.3.The presence of a previous restoration of the tooth.4.Participants who not signed the written consent form.5.Patient with PAI score \>2.
• Severe pulpits-There are any clinical symptoms of Severe spontaneous pain and clear pain reaction to warmth and cold stimuli, often, sharp to dull throbbing pain, patients have trouble sleeping because of the pain (gets worse when lying down).7.Tooth is very sensitive to touch and percussion.
• Evidence of internal or external resorption, calcified canals, as assessed by radiographic examination.9.Patients with periodontal disease, swelling and sinus tract.10.A positive history of antibiotic use within 1 month and analgesic use within week before the treatment.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Interventions

Hemostasis; Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• dr. sanjay tewari

  PGIDS, Rohtak, Haryana 124001

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 9, 2025
• Study Start: July 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 9, 2025

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

IN (1)