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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05306535
Other study ID # Endodontic Pain
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date June 30, 2022

Study information

Verified date August 2022
Source Altamash Institute of Dental Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

One of the most important aspects of endodontic practice is to abate pain during and post root canal treatment. An endodontist by all means should provide a painless endodontic treatment to their patients. This study is carried out to determine the effect of occlusal reduction on relief of pain and percussion in patients with irreversible pulpitis and symptomatic apical periodontitis treated in a single visit root canal treatment. Pain will be assessed preoperatively and then post operatively after completion of the root canal at 6 hours, 12 hours, 24 hours, 48 hours and 72 hours following obturation of root canal.


Description:

The objective of this randomized clinical trial is to evaluate the impact of occlusal reduction on the incidence of post obturation pain. 56 patients will be allocated randomly into 2 groups keeping 28 patients in each group which will meet the inclusion criteria of the study, patients diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis and requiring porcelain fused to metal crown with age ranging from 18 to 50 years. In the interventional group 2mm reduction will be done and assessment will be done to confirm the absence of occlusal contact while in control group no modification will be carried out on the occlusal surface. Single visit endodontic treatment will be carried out with 2.5% sodium hypochlorite for disinfection of the canal followed by crown down technique using rotary nickel titanium files for shaping the canals followed by obturating the canals with lateral condensation technique. Pain will be assessed preoperatively and then post operatively at 6 hours, 12 hours, 24 hours, 48 hours and 72 hours following obturation of root canal. Visual Analogue Scale (VAS) will be used as a primary outcome measure.The VAS consists of a 10-cm line having two extremes NO PAIN and Extreme pain. Patients will be asked to choose the mark that represents their level of pain at the intervals mentioned above . Pain level are assigned to one of four categorical scores 1, None(0); 2, Mild (1-3) ; 3 Moderate (4-6); 4, Severe (7-10) 10. Tenderness to percussion will be evaluated postoperatively at 48 hour with readings either positive to tenderness or negative to tenderness Positive to tenderness will evaluate treatment not effective Negative to tenderness at 48 hour post obturation will evaluate treatment effectiveness Patients will be given placebo for administration in case severe pain and ibuprofen 400mg if the pain persisted. Documentation of intake of either placebo or analgesic will be done by the patient.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date June 30, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - No medical history - patients suffering from Symptomatic Irreversible Pulpitis - patients suffering from Apical Periodontitis - patients requiring porcelain fused to metal crown Exclusion Criteria: - Patients who were not suitable for conventional root canal treatment - multirooted teeth

Study Design


Intervention

Procedure:
Occlusal reduction
Occlusal reduction of the experimental single rooted tooth after root canal completion will be done to evaluation reduction in postoperative pain and sensitivity to percussion

Locations

Country Name City State
Pakistan Hira Danish Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
Altamash Institute of Dental Medicine

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post Obturation pain Postobturation pain is measured using the visual analogue scale(VAS) with readings from 0-10 where 0 represents no pain and 10 represents the worst pain measured. 6 hours upto 48 hours following obturation
Primary Tenderness to percussion Tenderness to percussion will be evaluated (score 0: no pain, score 1: slight pain score 2: severe pain) At 48 hours post completion of the root canal treatment
Secondary Incidence of placebo and analgesic intake The incidence of placebo and number analgesic taken will be recorded by the patient from 6 hours up to 48 hours following completion of root canal
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