MedPath

A clinical trial in testing a new way to treat infected mature teeth.

Phase 2
Conditions
Health Condition 1: K04- Diseases of pulp and periapical tissues
Registration Number
CTRI/2024/02/062552
Lead Sponsor
REZVANA BEGUM
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Nonvital single rooted maxillary anterior tooth with a mature root and a periapical lesion with a periapical index score equal to or more than 3 according to the classification of orstavik et al 1986

Radiologic confirmation of a single rooted necrotic tooth with a single root canal

Exclusion Criteria

Teeth with severe coronal defects that require post and core as final restoration

Non-restorable teeth

Presence of other pathological root resorption

Teeth with previous root canal treatment

Presence of periodontitis

Pregnant or lactating females

A history of systemic diseases or any allergies

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary outcome is obtained by evaluating the clinical and radiographic outcomes <br/ ><br>Success <br/ ><br>After REP <br/ ><br>the tooth is asymptomatic absence of percussion pain sinus or fistula <br/ ><br>The radiographic examination demonstrates the absence or reduced apical shadow <br/ ><br>Failure <br/ ><br>After REP <br/ ><br>the tooth is symptomatic with symptoms of apical infection such as pain and fistula <br/ ><br>The radiographic examination demonstrates a new onset apical shadow or an enlarged apical shadow <br/ ><br>Timepoint: Baseline 3month 6month 12month
Secondary Outcome Measures
NameTimeMethod
The secondary outcomes include the subjective response from the patient to thermal & electric <br/ ><br>stimuli, which reflects the responsiveness of regenerative pulpal sensory neurons. <br/ ><br>POSITIVE RESPONSE NORMAL RESPONSE The test tooth is considered normal if <br/ ><br>the patient responds similarly to when a control <br/ ><br>tooth is tested <br/ ><br>NO RESPONSE The tested tooth is considered to have no response if the patient does not <br/ ><br>respond to stimulation <br/ ><br>Timepoint: Baseline 3month 6month 12month
© Copyright 2025. All Rights Reserved by MedPath