Comparative Evaluation of the Clinical Outcome of Direct Pulp Capping Treatment in Permanent Molars

NCT06599814 | Recruiting DMC

• 1 other identifier: KFSIRB200-245
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial will be performed during June 2024 and December 2024. The study is conducted following the Declaration of Helsinki Ethical principles for medical research involving human subjects after being independently reviewed and approved by the Institution's Ethical Committee and is designed in accordance with CONSORT 2010. Selected patients who are between 19 and 40 years of age had undergone conservative treatment for deep caries management in their permanent teeth in the restorative and endodontic departments, faculty of dentistry, Kafrelsheikh university. The patients are then assigned randomly into four different groups for this randomized clinical study. The decision for direct pulp capping will be made after informing the patients about all the pulp capping procedures that are suggested. Furthermore, any possible complications, postoperative discomfort, or failure of the treatment will be discussed with the patient. All included patients signed a written informed consent before enrollment

Conditions

Vital Pulp Therapy

Outcome Measures

Primary Outcomes (2)

• postoperative pain

  The postoperative pain was assessed on the numeric rating scale (NRS-11) 1,3 and 6 months after intervention. The examiner asked the patient to quantify his/her maximum pain intensity within the last 24 hours on a scale of 0 to 10. The following anchors were used to describe the rating scale: 0 = no pain/pain-free and 10 = worst pain imaginable.

  (1, 3, and 6 months

• Radiographic assessments

  The digital periapical radiographs were captured using a paralleling technique with Rinn film holders to allow standardization. Each root was examined for the presence, absence, and change (increase/decrease) in size of any PA radiolucency. A PA lesion or PDL gap expansion was referred to as a PA radiolucency. Less than double the equal healthy PDL space of the neighboring healthy tooth was considered a widening of the PDL space. A PA lesion was identified as radiolucency connected to the root's radiographic apex, greater than double the PDL space's breadth

  (1, 3, and 6 months

Study Arms (4)

RetroMTA Conventional group

ACTIVE COMPARATOR

After controlling the bleeding, RetroMTA is mixed with the supplied liquid at a W/P ratio of 3 drops per 0.3 g. After 150 seconds, selective etching, application of adhesive material and application of resin composite restorations will occur according to the manufacturer's instructions.

Procedure: vital pulp therapy

TheraCal Conventional group

ACTIVE COMPARATOR

Subsequent to controlling the bleeding, using a needle-tip syringe, gently apply TheraCal LC resin-modified calcium silicate (Bisco Inc., Schamburg, IL, USA) light-hardening paste to the exposed portion of the pulp in accordance with the manufacturer's recommendations for thickness (1 mm) and curing time (20 Seconds).

Procedure: vital pulp therapy

RetroMTA laser group

ACTIVE COMPARATOR

Consequent to controlling the bleeding, Diode laser is focused to the exposure sites before the placement of pulp capping materials. The hemostasis is obtained by the diode 808-nm, laser-assisted procedure (Picasso-AMD, USA) using 1.5 W, continuous wave, fiber diameter of 400 μm, non-initiated and in contact mode, Decontamination of the cavity is performed by 1 W, continuous wave, fiber diameter of 400 μm, non-initiated and in contact mode, tip angle set at 90°, an area with 2-mm diameter per second, power density 31.83 W/cm2, energy density 31.83 J/cm2 per second (28), and circular movement (23). The use of diode laser will be used for 1 to 3 Application of RetroMTA are occurred as RetroMTA Conventional group.

Procedure: vital pulp therapy

TheraCal laser group

ACTIVE COMPARATOR

Consequent to controlling the bleeding, Diode laser is focused to the exposure sites before the placement of pulp capping materials. The hemostasis is obtained by the diode 808-nm, laser-assisted procedure (Picasso-AMD, USA) using 1.5 W, continuous wave, fiber diameter of 400 μm, non-initiated and in contact mode, Decontamination of the cavity is performed by 1 W, continuous wave, fiber diameter of 400 μm, non-initiated and in contact mode, tip angle set at 90°, an area with 2-mm diameter per second, power density 31.83 W/cm2, energy density 31.83 J/cm2 per second (28), and circular movement (23). The use of diode laser will be used for 1 to 3 Application of TheraCal are occurred as TheraCal Conventional group.

Procedure: vital pulp therapy

Interventions

vital pulp therapy PROCEDURE

vital pulp therapy using two bioactive materials TheraCal and RetroMTA as direct pulp caping materials conventionally and test using Diode laser before application of these materials

RetroMTA Conventional group; RetroMTA laser group; TheraCal Conventional group; TheraCal laser group

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• In all patients, the pulp had been exposed because of caries removal. Data collection included clinical pulp capping respecting the following criteria.

You may not qualify if:

• Individuals who are 19 to 40 years old.
• Permanent teeth that have not been repaired and have extensive caries on their occlusal and proximal surfaces, extending more than two-thirds of the dentin near the pulp.
• Vital teeth; asymptomatic teeth (not sensitive to pressure, percussion, or palpation, and no spontaneous pain); sinus tract devoid of swelling and abscess; abnormal mobility absent; no history of spontaneous pain; mild, dull, and tolerable pain associated with eating and drinking cold drinks.
• Ethyl chloride cold tests, gutta-percha heat testing, palpation, percussion, and the lack of radiological symptoms in periapical radiographs are used to assess the life of the teeth prior to treatment. After the stimulus is removed, pain from a pulp test that is triggered by either heat or cold should subside.
• In periapical radiography, none of the following conditions should be present: normal lamina dura and periodontal ligaments, no internal or external root resorption, and no radiolucency in the furcation area or periapical region.
• The exposed area's diameter ranges from 0.5 to 1 mm.
• Participants' acceptance of the research program.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

kafrelsheikh University

Kafr ash Shaykh, Kafr El-Shaikh, 33511, Egypt

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of Endodontics

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: September 19, 2024
• Study Start: June 1, 2024
• Primary Completion: December 10, 2024
• Study Completion: January 10, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

EG (1)