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HEMOSTASISNCT06765447

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

A study testing hemostasis with 3% NaOCl in direct pulp capping and hemostasis with diode laser in direct pulp capping in people with HEMOSTASIS and DIRECT PULP CAPPING, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
HEMOSTASIS, DIRECT PULP CAPPING
What is being tested?
hemostasis with 3% NaOCl in direct pulp capping and hemostasis with diode laser in direct pulp capping
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteIndia
Study dates
1 Jul 2023to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 1.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
  • -

Who cannot join

  • 1.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.
  • 6.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.
  • 8.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.
  • -

Trial locations and contacts

1 site in 1 country.

India1 site
  • PGIDS

    Rohtak, Haryana, 124001

Other trials in India

About this study

Official title: EFFECT of USE of DIODE LASER and 3% NaOCl for HEMOSTASIS in DIRECT PULP CAPPING on OUTCOME in MILD and MODERATE PULPITS:A PROSPECTIVE CLINICAL STUDY.

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.

Read the detailed description

Rationale: - Preservation of pulp vitality is a critical factor in long-term tooth survival. In deep carious lesion, vital pulp therapy procedures in the form of direct pulp capping is more conservative treatment strategy. When applied to dental tissues lasers have shown their potential to increase healing, control hemorrhage, stimulate dentinogenesis and preserve vitality of the dental pulp. Laser amplifies the healing process by stimulation of cell regeneration and is capable of inducing the odontoblasts for laying down tertiary dentine and forming a dentine bridge. Diode laser has great penetration, eliminate microorganism and has been shown to reduce post operative pain (Genc Sen, O.et al).Iraj Yazdanfar et al. evaluated the efficiency of diode 808-nm laser combined with Theracal LC in direct pulp capping performed on the caries-exposed pulps of permanent teeth and radiographically compared the thickness of dentin bridge formed for a 6-month follow-up. They found favorable results but recommended further studies with larger sample sizes, longer follow-up periods, and different capping material are needed to prove the effectiveness of the diode laser.

AIM \& OBJECTIVES- To evaluate the effect of use of diode laser and 3% NaOCl for hemostasis in Direct Pulp Capping in mild and moderate pulpitis on success and survival.

Primary objective-To determine the success rate and survival of diode laser and sodium hypoclorite as hemostatic agent in direct pulp capping with biodentine, based on clinical findings at 1week,3 months and both clinical and radiographic findings at 6 and 12 months.Secondary objective-To assess the post operative pain from Day 1 to Day 7 post treatment(NRS score).

Participants:

Inclusion Criteria: -Healthy patients (ASA I ).Patients falling in the age group of 18-45 years.Unrestored Permanent mandibular posterior teeth.Extremely deep caries are 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. (L.BJORNDAL et al.2019)Only occlusal pulp exposure due to caries.Vital teeth 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 (W. J. Wolters et al.).Exposure size 0.5 to 1 mm.

Exclusion Criteria: -No pulp exposure after caries excavation.No bleeding after pulp exposure.Participants who will not signed the written consent form.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). Tooth is very sensitive to touch and percussion.Evidence of internal or external resorption, calcified canals, as assessed by radiographic examination.Patients with periodontal disease, swelling and sinus tract.A positive history of antibiotic use within 1 month and analgesic use within week before the treatment.

Sample size: - 64 in one group Methods: - • The teeth were evaluated by periapical radiographs, periodontal probing, percussion test, and sensibility assessment with cold test and electric pulp test.All periapical radiographs were exposed by using constant kVP, mA, and exposure time (70 KVP, 8 mA, and 0.8 sec.).The tooth was anesthetized using lidocaine 2% with epinephrine 1:80,000 and subsequently isolated using rubber dam.The tooth was disinfected by scrubbing with 2% chlorhexidine and 75% isopropyl alcohol. Round diamond bur and high-speed handpiece with copious water irrigation was used to remove carious enamel and further round bur with low-speed handpiece was used to remove carious dentin.After pulp exposure, tooth was randomly allocated to one of the study groups for hemostasis achievement.To avoid selection bias,the randomization for diode laser and 3% NaOCl was done after pulp exposure .This was involve picking a closed envelope containing the instruction to either use NaOCl 3% or diode laser for hemostasis by an investigator who is not the part of study.

In GROUP 1,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.

In GROUP 2, 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. 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.Biodentine (Septodont, Saint-Maur-des-Fosses, France) aa was mixed according to manufacturer's instructions and applied directly onto the exposed pulpal site in 1- 2mm layer thickness. After 12-15 mins when Biodentine sets, application of RMGIC liner was done. This was followed by etching with 37% phosphoric acid for 15 seconds and rinsing with water. The cavity was then air dried and bonding agent was applied which was cured for 20 seconds. The cavity was then restored with composite using incremental technique FOLLOW UP:The patients were recalled periodically at 1 week, 3months, 6 months and 12 months after the direct pulp capping procedure for clinical evaluation (post operative sensitivity, pain, tenderness, vitality) and at 6 months and 12 months for radiographic (widening of periodontal ligament space and periapical radiolucency) evaluation.

Being tested
hemostasis with 3% NaOCl in direct pulp capping, hemostasis with diode laser in direct pulp capping

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hemostasis with 3% NaOCl in direct pulp cappingProcedure or surgery

    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.

  • hemostasis with diode laser in direct pulp cappingProcedure or surgery

    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.

Study groups in NCT06765447
Study groupRoleWhat they receive
3% NaOClActive comparatorafter 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
Receives: Procedure: hemostasis with 3% NaOCl in direct pulp capping; Procedure: hemostasis with diode laser in direct pulp capping
diode laserExperimentalHemostasis 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
Receives: Procedure: hemostasis with 3% NaOCl in direct pulp capping; Procedure: hemostasis with diode laser in direct pulp capping

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: [ baseline to 12 months]

  2. 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

    Measured: [Time Frame: baseline to 12 months]

Secondary outcomes (1)
  1. 3. Post Operative Pain

    To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score100 means maximum pain. To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score 100 means maximum pain

    Measured: [Time Frame: Baseline to 7 days]]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2025
  2. Study start1 Jul 2023
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06765447
Sponsor's protocol ID
Dr. Varsha
Status last verified
Jun 2023
First submitted
3 Jan 2025
Last updated
9 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing hemostasis with 3% NaOCl in direct pulp capping and hemostasis with diode laser in direct pulp capping in people with HEMOSTASIS and DIRECT PULP CAPPING, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1.Clinical success rate (time frame: [ baseline to 12 months]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.

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