NCT05306535

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

Same day

First QC Date

March 15, 2022

Last Update Submit

August 21, 2022

Conditions

Keywords

Occlusal reduction

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Incidence of placebo and analgesic intake

    from 6 hours up to 48 hours following completion of root canal

Study Arms (2)

occlusal reduction

EXPERIMENTAL

Performing occlusal reduction on the experimental tooth until absence of occlusal contact is confirmed following completion of the endodontic treatment

Procedure: Occlusal reduction

control

NO INTERVENTION

No occlusal reduction or modification of the occlusal anatomy will be performed

Interventions

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

occlusal reduction

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No medical history
  • patients suffering from Symptomatic Irreversible Pulpitis
  • patients suffering from Apical Periodontitis
  • patients requiring porcelain fused to metal crown

You may not qualify if:

  • Patients who were not suitable for conventional root canal treatment
  • multirooted teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hira Danish

Karachi, Sindh, 75500, Pakistan

Location

MeSH Terms

Conditions

Pain, PostoperativePostoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Hira Danish

    Employee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 15, 2022

First Posted

April 1, 2022

Study Start

April 1, 2022

Primary Completion

April 1, 2022

Study Completion

June 30, 2022

Last Updated

August 24, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations