Outcome Following Endodontic Treatment Using Traditional Access Versus Conservative Access

Pulpitis - Irreversible Clinical Trial

Official title:

Comparative Evaluation of Outcome Following Endodontic Treatment Using Traditional Versus Conservative Access in Mandibular Molars With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05402098
• Other study ID #: A Ramani
• Status: Recruiting
• Phase: N/A
• Start date: May 12, 2022
• Est. completion date: September 2023

Study information

• Verified date: May 2022
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: DR. ANKITA RAMANI, MDS
• Phone: +919582841539
• Email: ramaniankita95[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare the outcome of endodontic treatment using conservative or traditional access design in permanent molars with clinical signs indicative of irreversible pulpitis

Description:

After thorough history and clinical and radio graphic examination, and confirmation of eligibility for the study, written informed consent will be obtained after explaining the procedure and its associated risks and benefits. Clinical diagnosis of symptomatic irreversible pulpitis will be established based on a history of spontaneous pain or pain exacerbated by cold stimuli and lasting for a few seconds to several hours (lingering pain) compared to control teeth and which is reproducible using cold testing. Once included, study subjects will be randomly allocated to either traditional access or conservative access group. Subsequently biomechanical preparation will be carried out using standard protocol with the use of rotary NiTi file system followed by root canal filling using gutta percha and zinc oxide eugenol sealer. Teeth will be restored using composite resin in the same appointment. Pain analysis will be carried out preoperatively and postoperatively at every 24 hours till 7 days after intervention. All the subjects will be followed up for evaluation of success at 6 and 12 months from baseline.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• The patient should be =18 years of age.
• Restorable mandibular molars with extremely deep caries involving occlusal surface only
• Clinical diagnosis of symptomatic irreversible pulpitis with PAI score =2.
• Tooth should give positive response to pulp sensibility testing.
• Tooth with probing pocket depth and mobility are within normal limits.
• Non-contributory medical history.

Exclusion Criteria:

• Teeth with immature roots.
• No pulp exposure even after caries excavation.
• Teeth with signs of pulpal necrosis including sinus tract or swelling.
• Teeth with percussion sensitivity
• Positive history of antibiotic use in the past 1 month or requiring antibiotic prophylaxis
• Had taken analgesic in past 3 days
• Teeth with pathologic changes such as internal or external resorption
• Teeth with morphological variation
• Teeth with root canal calcification
• Teeth with fixed full coverage prosthesis

Related Conditions & MeSH terms

• Pulpitis
• Pulpitis - Irreversible

Intervention

Procedure:
• Endodontic treatment using traditional access
Endodontic treatment will be carried out following complete removal of pulp chamber roof and achieving straight line access
• Endodontic treatment using conservative access
Endodontic treatment will be carried out following partial removal of pulp chamber roof, extended only to the extent which helps to locate all the orifices with no efforts will be made to achieve straight line access

Locations

Country	Name	City	State
India	Dr. Ankita Ramani	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical and radiographic success	CLINICAL SUCCESS CRITERIA: Absence of spontaneous pain, discomfort, swelling, sinus tract or tenderness to palpation or percussion.; 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 Orstavic et al. Evaluation of both clinical and radiographic outcome is must for analyzing the actual success of therapeutic technique.; Number of participants fulfilling both clinical as well as radiographic success criteria will be considered in success category.	Baseline to 12 Months
Secondary	Pain analysis	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.	Baseline to 7 days