Health TrialsbyHealthPanel

Postoperative Pain Comparison of Two Root Canal Sealers in Irreversible Pulpitis

ConditionPost Operative Pain After Root Canal Therapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20-40
SponsorArmed Forces Institute of Dentistry, Pakistan

About this trial

This study, approved by the Institutional Ethics Review Committee, AFID (Annex "A"), will involve 62 eligible patients from the Operative Dentistry Department, Armed Forces Institute of Dentistry. Patients (and their guardians) will receive a detailed explanation in Urdu, and written informed consent will be obtained (Annex "B").

Study Design:

Randomized Controlled Trial: Patients will be randomly divided into two equal groups using a scientific random number table.

Inclusion Screening: Includes medical history, clinical examination, periapical radiographs.

Treatment Protocol:

Root canal therapy under local anesthesia with rubber dam isolation.

Working length determined using DentaPort ZX apex locator, confirmed with radiograph.

Instrumentation: ProTaper Universal hand files up to F2 with 5.25% NaOCl irrigation.

Patency confirmed with #10 K-file between each instrument change.

Final flush with 17% EDTA.

Calcium hydroxide used as intracanal medicament for microbial control.

Temporary restoration using Cavit.

Recall and Evaluation: After 1 week, asymptomatic patients (VAS score 0 and dry canals) will be selected for obturation.

Obturating Materials:

Group 1: AD Seal + F2 single cone gutta-percha (Sure Endo). Group 2: Pulp-dent Sealer + F2 single cone gutta-percha (Sure Endo). Sealers will be mixed per manufacturer's instructions, applied using lentulospiral. The apical extent of the master cone will be confirmed radiographically.

All procedures will be carried out by a single operator. Final restoration will be done using composite, and patients will be referred for full coverage crowns.

Post-Treatment Pain Assessment:Patients will receive a pain diary with a Visual Analogue Scale (VAS) from 0 (no pain) to 10 (severe pain).

Pain will be recorded at 24 hours, 72 hours, and 7 days post-treatment. Analgesic use (type and quantity) will also be noted. Diaries will be collected at the follow-up visit.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Permanent mandibular first molar with irreversible pulpitis without swelling and sinus.

Patients of male gender between 20-40 years of age.

Systemically healthy patients with no other co morbidity classified as ASA-I

Patients who agree to attend for re call appointments and provide a written consent

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Resin Based sealer

    Drug

    Post-operative pain after Root Canal Therapy by using resin based sealer

  • ZnO eugenol based sealers

    Drug

    Post-operative pain after Root Canal Therapy by using ZnO eugenol based sealer

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Resin based sealerActive comparator 1 intervention
Group B: ZnO eugenol based sealerActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Post-Operative pain by using resin based sealer on visual analogue scale

endodontic sealer AD seal and core obturating material single cone F2 gutta parcha(Bio GP points-sure endo, sure dent cooperation),post-operative pain on visual analogue scale.

Time frame
24 hours
2

Post-Operative pain by using resin based sealer on visual analogue scale

endodontic sealer AD seal and core obturating material single cone F2 gutta parcha(Bio GP points-sure endo, sure dent cooperation),post operative pain on visual analogue scale

Time frame
72 hours
3

Post-Operative pain by using resin based sealer on visual analogue scale

endodontic sealer AD seal and core obturating material single cone F2 gutta parcha(Bio GP points-sure endo, sure dent cooperation),post operative pain on visual analogue scale

Time frame
7 days
4

Post-Operative pain by using ZnO engenol based sealer on visual analogue scale

endodontic sealer pulp-dent sealer and core obturating material single cone F2 gutta parcha. (Bio GP points-sure endo, sure dent cooperation),post-operative pain on visual analogue scale.

Time frame
24 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Armed Forces Institute of Dentistry, Pakistan

Lead sponsor

Source ClinicalTrials.gov
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