COMPARATIVE EVALUATION OF DIRECT PULP CAPPING AND COMPLETE PULPOTOMY IN MATURE PERMANENT MANDIBULAR MOLARS WITH CLINICAL SIGNS INDICATIVE OF MODERATE PULPITIS

NCT06447753 | Recruiting

• 1 other identifier: Sakshi
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

Title: Comparative evaluation of direct pulp capping and complete pulpotomy in mature permanent mandibular molars with clinical signs indicative of moderate pulpitis: Randomized Clinical Trial Rationale: According to new Wolters pulpal clinical classification, Moderate pulpitis exhibit symptoms of prolonged reaction to cold, which can last for minutes, possibly percussion sensitive and spontaneous dull pain which are correspond to irreversible pulpitis. Complete/partial pulpotomy are suggested to be the choice of treatment for such cases. It has been suggested that infection is often the cause of inflammation, an inflamed pulp should be able to heal if the source of infection is eliminated as in other body organs. Removal of trigger (i.e. caries) followed by application of biocompatible material which makes a good seal in a sterile environment has potential to allow for recovery and healing of the inflamed pulp tissue which is thought to be beyond recovery. Based on this premise, DPC can be considered as minimally invasive approach for the management of teeth with inflamed pulps in place of the conventional approach of partial/complete pulpotomy in adults Research Question Does Direct Pulp Capping have comparable outcome with complete pulpotomy in mature permanent teeth with clinical signs indicative of moderate pulpitis?

Conditions

Moderate Pulpitis

Outcome Measures

Primary Outcomes (1)

• Clinical and radiographic success

  Clinical success criteria No history of spontaneous pain or discomfort except for the initial days after treatment. No tenderness to palpation or percussion and the tooth is functional. Normal mobility and probing pocket depth. Soft tissues around tooth are normal with no swelling or sinus tract. Radiographic success criteria No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis. Periapical Index score 1 or 2 according to Orstavic6 et al.

  12 months

Secondary Outcomes (1)

• Pain incidence and reduction

  7 days

Study Arms (2)

Direct pulp capping

EXPERIMENTAL

Procedure: Direct pulp capping

Complete pulpotomy

ACTIVE COMPARATOR

Procedure: Complete Pulpotomy

Interventions

Direct pulp capping PROCEDURE

after caries excavation, the pulp will be inspected visually. If bleeding present, sterile cotton soaked in 3% NaOCl will be placed over the pulpal wound for 2 minutes, repeated for up to 6 min if required. Cases in which bleeding will not stop within 6 minutes will be excluded from the study and further managed by RCT. The exposed pulp will be capped with MTA which will be freshly mixed according to manufacturer's instructions and placed in thickness of 2 to 3 mm over the pulp exposure site using an amalgam carrier following which the cavity floor will be dabbed with moist sterile cotton pellet to ensure the setting of MTA, followed by application of a layer of light-cure RMGIC over MTA and light-curing for 20s. Then tooth will be restored using composite resin following etch and rinse technique.

Direct pulp capping

Complete Pulpotomy PROCEDURE

exposed pulp tissue will be amputated using fresh sterile large round diamond bur in a high-speed hand-piece under water coolant 28to the level of canal orifices. The pulp wound will be irrigated with 3% NaOCl. For hemostasis, sterile cotton soaked in 3% NaOCl will be placed over the pulpal wound for 2 minutes, repeated for up to 6 min if required. Root canal therapy will be initiated in cases in which haemostasis is not achieved within 6 minutes. After hemostasis, ProRoot MTA will be placed in thickness of 2 to 3 mm over the pulp exposure site using an amalgam carrier. After placement, the cavity floor will be dabbed with moist sterile cotton pellet to ensure the setting of MTA, followed by application of a layer of light-cure RMGIC over MTA and light-curing for 20s. The tooth then will be restored using composite resin following etch and rinse technique.

Complete pulpotomy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. The patient should be ≥18 years of age. 2. Restorable mature permanent 1 st and 2nd Mandibular molars with extremely deep caries (≥2/3 dentine involvement) 3. Tooth should give positive response to pulp sensibility testing. 4. Clinical diagnosis of moderate pulpitis. 5. Radiographic finding of periapical index (PAI) score ≤2. 6. Healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit).

You may not qualify if:

• Teeth with immature roots.
• No pulp exposure after caries excavation.
• Bleeding could not be controlled in 6 minutes.
• Signs of pulpal necrosis, sinus tract, swelling, insufficient bleeding after pulp exposure.
• History of analgesic intake in previous 1 week, or antibiotic intake in 1 month.
• Internal/external resorption.
• Contributory medical history (alcoholism, smokers, diabetic, hypertension, drug dependency, Heart or valve disease, hepatitis, herpes, immunodeficiency (HIV), infectious diseases, kidney or liver, migraine) -

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

RECRUITING

Study Officials

• Sanjay Tewari, MDS

  pgids rohtak

  STUDY DIRECTOR

Central Study Contacts

Vinay Kumar, MDS

CONTACT

8901149107; 29vinaykr@gmail.com

Sakshi Bansal

CONTACT

8570018172; bansal9sakshi@gmail.com

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: SPONSOR

Study Record Dates

• First Submitted: June 2, 2024
• First Posted: June 7, 2024
• Study Start: June 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

IN (1)