Clinical trial NCT06632015: Evaluation of the Effect of Different Medicaments Used in Teeth With Irreversible Pulpitis and Symptomatic Apical Periodontitis on Post-Operative Endodontic Pain
Official title: Evaluation of the Effect of Different Medicaments Used in Teeth With Irreversible Pulpitis and Symptomatic Apical Periodontitis on Post-Operative Endodontic Pain: A Randomized Controlled Double-Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irreversible Pulpitis
Periodontitis, Apical, Symptomatic
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this randomized clinical study, the aim is to compare the effects of calcium hydroxide, sodium diclofenac, and the combined use of calcium hydroxide with sodium diclofenac as an intracanal medicament on postoperative endodontic pain in teeth with irreversible pulpitis and symptomatic apical periodontitis.

Primary Hypothesis: There is no effect of calcium hydroxide, sodium diclofenac, and the combined use of calcium hydroxide with sodium diclofenac as an intracanal medicament on postoperative endodontic pain in teeth with irreversible pulpitis and symptomatic apical periodontitis.

Materials and Methods:

In this study, ninety patients diagnosed with irreversible pulpitis and symptomatic apical periodontitis, exhibiting spontaneous pain and percussion pain levels above 50 on a 100 mm Visual Analog Scale (VAS) during the preoperative period, were included. After root canal preparation using Reciproc files (VDW), the patients were randomly assigned to three groups based on the intracanal medicament used: calcium hydroxide group (n=30), calcium hydroxide and diclofenac sodium combination group (n=30), and diclofenac sodium group (n=30). Postoperative spontaneous pain scores were recorded daily using the VAS for one week. The collected data were statistically analyzed.

Detailed description: A web program available at www.randomizer.org was used for randomization. Based on the power analysis conducted, the minimum required number of patients for each group was determined to be twenty-six (effect size: 0.797; 80% power). Therefore, 30 patients were included in each group. Patients included in the study were informed about the research, and written consent was obtained from each participant. These patients were rated for preoperative spontaneous and percussion pain on the Visual Analog Scale (VAS). Demographic data and contact information of the patients were recorded.

All patients received mandibular block anesthesia with 4% articaine containing 1:200,000 epinephrine. After preparing the access cavity, the treatment procedure was completed using rubber dam isolation. An apex locator was utilized to determine the working length. The root canals were irrigated with 2 mL of 2.5% NaOCl, and Reciproc files (R25, R40) were used for the root canal shaping process. The root canals were expanded using the VDW Resiproc Ni-Ti rotary file system and the X-Smart Plus (Dentsply, Maillefer) endodontic motor in the reciprocating mode. Following the manufacturer's recommendations, the crown-down technique was employed, with mesial canals prepared to R25 and the distal canal prepared to R40 (0.06), achieving an apical width of #0.40 mm for the working length final preparation. Each root canal was prepared up to three file sizes larger than the first file that reached the working length. Between each file change, 2 mL of 2.5% NaOCl was used. A 10 K-file was utilized to maintain the apical patency between file changes. Finally, the last irrigation was performed with 5 mL of 2.5% NaOCl and 5 mL of 17% EDTA. Subsequently, the root canals were dried with paper points, and the selected intracanal medicament was placed in the root canals.

A total of 90 patients were randomly divided into three groups based on the intracanal medicament used.

Groups:

* Group 1: 1 mL of distilled water with 1 g of Ca(OH)2 powder
* Group 2: 1 mL of distilled water with 1 g of sodium diclofenac
* Group 3: 1 mL of distilled water with 950 mg of Ca(OH)2 powder + 50 mg of sodium diclofenac A simple randomization technique was utilized by an independent person to generate a random sequence online (www.random.org) with numbers ranging from 1 to 90. These numbers were then randomly assigned to three study groups based on the intracanal medicament placement (A: Ca(OH)2 powder, B: sodium diclofenac, C: Ca(OH)2 powder + sodium diclofenac) using the web program. After generating the random codes (e.g., 3-C, 14-B, 56-A), the intracanal medicaments were stored in sealed envelopes. This ensured that the treating physician had no information regarding the type of intracanal medicament or the patient group.

This study was designed as a randomized, controlled, double-blind, single-center clinical trial. The researcher, patients, and analyst (biostatistician) were blinded to the type of intracanal medicament used. The intracanal medicaments were placed into the root canals at a level approximately 1 mm short of the working length using a lentulo. The amount of intracanal medicament (1 g of powder and 1 mL of distilled water) was standardized to be equal across all groups. Sterile cotton pellets were used to close the canal entrances, and Cavit was employed to fill the access cavities.

Patients were asked to rate their pain daily on a VAS form for one week. They were prescribed 400 mg of ibuprofen to take in case of severe pain and were instructed to record the number of analgesics taken and the days they used them. Patients were recalled for a follow-up visit one week after the treatment. During this second session, after the percussion test conducted by the operator, the intracanal medicament was removed using sterile saline, 5 mL of 17% EDTA, and the master apical file. Additionally, the 5% EDTA was activated using sonic activation. The root canals were filled with gutta-percha and a bioceramic-based paste using the lateral compaction technique. The final restoration was performed in the pulp chamber using flowable composite resin and nanohybrid composite resin.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with irreversible pulpitis (characterized by prolonged pain in response to cold tests) and symptomatic apical periodontitis (characterized by percussion pain) in their lower molar teeth.
2. No systemic diseases.
3. Aged over 18 years.
4. Patients with preoperative spontaneous pain and percussion pain levels equal to or above 50 mm on the Visual Analog Scale (VAS).
5. Teeth with a Periapical Index (PAI) score of 1 or 2, as defined by Orstavik et al.
6. Patients classified as ASA I by the American Society of Anesthesiologists (ASA).

Exclusion Criteria:

1. Patients with psychiatric disorders, systemic diseases, or allergic reactions.
2. Pregnant patients or those over 65 years of age.
3. Patients with parafunctional habits, such as bruxism.
4. Teeth with a history of swelling in the sinus pathway or associated teeth.
5. Teeth that are not in occlusion with the opposing tooth.
6. Presence of periodontal pockets greater than 3 mm in the relevant tooth.
7. Severely damaged teeth.
8. Teeth with periapical radiolucency.
9. Teeth with root resorption, root fractures, or ankylosis.
10. Teeth that have undergone previous root canal treatment.
11. Patients who used any analgesics within 3 days prior to root canal treatment.
12. Patients who experienced any complications during the treatment were excluded from the study.

Primary outcomes:
measure: post-operative pain
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Hatay
country: Turkey
facility: Hatay Mustafa Kemal University
state: Antakya
Study officials:
References: