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Single And Multiple-visit Endodontic Retreatment Outcome.

Outcome Following Single-visit And Multiple-visit Nonsurgical Endodontic Retreatment

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04390789
Enrollment
90
Registered
2020-05-18
Start date
2019-12-15
Completion date
2021-06-15
Last updated
2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apical Periodontitis

Keywords

Nonsurgical Retreatment, Single Visit, Multi visit, Calcium Hydroxide, Outcome

Brief summary

This study will compare the outcome of single visit retreatment and multi-visit retreatment in cases of failed root canal treated teeth.

Detailed description

Retreatment is defined as a procedure to remove root canal filling materials from the tooth, followed by cleaning, shaping and obturating the canals.Although initial root canal therapy has been shown to be a predictable procedure with a high degree of success, failures can occur after treatment. Recent publications have reported failure rates of 14%-16% for initial root canal treatment. In order to prevent tooth loss in such cases, nonsurgical retreatment or apical surgery is often indicated. In this study subjects will be assigned to either the single-visit and multi-visit nonsurgical endodontic retreatment. The allocation will be performed once the chemomechanical preparation is completed. Clinical and radiographic success rate will be considered as primary outcome. Follow up will be carried out every 3 months, till 12-month period. Pain intensity will be considered as secondary outcome.

Interventions

PROCEDURENon surgical Single visit Retreatment

Non-surgical endodontic retreatment will be carried out in single visit.

PROCEDUREMulti visit Retreatment with calcium hydroxide dressing

In this group,GP removal and biomechanical preparation will be carried out in first visit,after which calcium hydroxide dressing will be placed and temporarily restored.after 7 days,in second visit obturation will be done followed by permanent restoration

Sponsors

Postgraduate Institute of Dental Sciences Rohtak
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Patient willingness to participate in the study. * Previously root filled Permanent teeth with post-treatment apical periodontitis requiring nonsurgical root canal retreatment. * Failure of previous root canal treatment will be determined based on clinical and radiographic findings. Clinical indicators of failure will include pain, tenderness to palpation/percussion, swelling, sinus tract.Radiographic criteria will include persistent periapical radiolucent lesions in teeth in which initial treatments were performed at least 4 years previously. * Root canal fillings no more than 4mm short of the apex. * Patients showing no significant systemic disease

Exclusion criteria

* Patients who are pregnant, diabetic, immunocompromised, serious medical illness or requiring antibiotic premedication. * Patient under 18 years of age. * Patient under corticosteroid use. * Patients with history of antibiotic use in last 3 months or analgesic use in last one week will also be excluded. * Multiple teeth that require treatment to eliminate the possibility of pain referral.Patients with unrestorable carious lesions, fractures involving the periodontium, and/or periodontal pockets ≥ 4mm deep or having marginal or furcal bone loss due to periodontitis . * Teeth with the procedural errors preventing access to apical third and missed canals will be excluded. * Teeth that are not suitable for rubber dam isolation. * Teeth with intraradicular post.

Design outcomes

Primary

MeasureTime frameDescription
Clinical and radiographic successBaseline to 1 yearCriteria of clinical success: Absence of pain and tenderness to palpation/ percussion, absence of sinus or any associated soft tissue swelling, tooth mobility of grade-I or less, and no deterioration in periodontal probing depth as compared with baseline measurements Criteria of radiographic Success: PAI score 1-Normal periapical structures, OR PAI Score 2-Small changes in bone structure. Criteria of radiographic Failure: PAI score 3-Changes in bone structure with some mineral loss, OR PAI Score 4-Apical periodontitis with well-defined radiolucent area, OR PAI Score 5-Severe periodontitis with exacerbating features

Secondary

MeasureTime frameDescription
Pain assessmentBaseline to 7daysVisual analogue scale (VAS) from 0 to 10 will be used to record preoperative and post -operative pain.

Countries

India

Contacts

Primary ContactKajal Bhayani
bhayanikajal@gmail.com7507962278
Backup ContactDR PANKAJ SANGWAN
drps_1@yahoo.com9996112202

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026