Comparison of Post-operative Pain Frequency

Fatima Memorial Hospital

Status: Completed

Conditions: Pain, Postoperative

Treatments: Procedure: ROOT CANAL TREATMENT

Study type: Interventional

Funder types: Other

Identifiers

NCT04944589

14345

Details and patient eligibility

About

The objective of this study is:

• To compare the post-operative pain frequency after single visit root canal versus multiple visit root canal treatment in patients with non-vital teeth
• Post-operative pain is less frequent after single visit root canal than multiple visit root canal treatment in patients with non-vital teeth.

Full description

METHODOLOGY This Randomized control trial was done in Outdoor patients Department of Operative Dentistry at Fatima Memorial Hospital. Informed written consent was taken from all patients who were willing to participate in the study. Patients who were diagnosed with non-vital teeth were considered for this study. Socio-demographic data and symptoms were recorded, subjects were examined and relevant investigations (vitality tests and radiographs) carried out. The patients were randomly divided into two groups through lottery method. Group A the treatment was done in one visit while in group B treatment was completed in two visits.

The standard procedure for both groups at first visit was administration of local anesthesia (1.8ml 2% Lignocaine with 1:10000 epinephrine), standard access cavity preparation followed by rubber dam isolation and pulp extirpation. After the confirmation of canal patency and working length radiograph, canals were prepared with the combination of hand files and engine-driven rotary nickel-titanium files (DENTSPLY Maillefer, Ballaigues, Switzerland) following manufacturer's instructions. 17%Ethylenediaminetetraacetic acid (EDTA )gel was used as a lubricant. Irrigation was performed with 2.5% NaOCl after each instrument in all cases. At the first visit, all teeth were prepared to working length and dried with paper points. Canals in Group A were filled with protaper universal gutta-percha (DENTSPLY Maillefer) and calcium hydroxide based sealer and restored with permanent restorative material in the same visit. In Group B after the canal preparation non-setting calcium hydroxide paste was placed with a sterile dry cotton pellet in the canal and tooth was restored with a minimum of 3.0mm Cavit. Patients in Group 2 were recalled after 1 week and the obturation technique same as Group 1 was followed in the second visit. After obturation, the patients in both the groups were recalled after 48 hours and assessed using visual analogue scale regarding presence and absence of post-operative pain. A value of 0-1 on Visual Analogue Scale (VAS) scale was considered as absence of pain.

The data was entered and analyzed in the SPSS-20. For descriptive analysis, mean and standard deviation was reported for age. Percentage for male and female participants was presented for gender distribution. The incidence of post-operative pain for single visit root canal and multiple visit root canal was determined. A chi-square test was used to determine the frequency of post-operative pain in both groups. A P value of 0.05 or less was taken as significant. Data was stratified more scientific manner in Pakistani population. So, the results of this study would add to the literature about the better, time saving and less painful (ROOT CANAL TREATMENT)RCT strategy in term of post- operative pain management.

Enrollment: 302 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• • Patients within age range 20-40 years.

  • Male/Female
  • Mature permanent first and second molar teeth (maxillary and mandibular)
  • Non-vital teeth (As defined in operational definitions)

Exclusion criteria

• • Any contraindication to local anesthesia, e.g. known allergy

  • Pregnancy.
  • endodontic re-treatment cases
  • Any physical or mental condition that would prevent jaw opening for the time required to complete the treatment.
  • Local acute infection/periapical radiolucency (diagnosed clinically, radio graphically )

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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302 participants in 2 patient groups

single visit root canal treatment(RCT)

Experimental group

Description:

RCT(ROOT CANAL TREATMENT) of this group was performed in single visit including access cavity, chemo-mechanical preparation and obturation, all were done in one visit

Treatment:

Procedure: ROOT CANAL TREATMENT

Multiple visit root canal treatment(RCT)

Experimental group

Description:

RCT(ROOT CANAL TREATMENT) of this group was performed in multiple visit including access cavity, chemo-mechanical preparation and obturation, all were done in two or three visits

Treatment:

Procedure: ROOT CANAL TREATMENT