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Single And Multiple-visit Endodontic Retreatment Outcome.

Not Applicable
Conditions
Apical Periodontitis
Interventions
Procedure: Non surgical Single visit Retreatment
Procedure: Multi visit Retreatment with calcium hydroxide dressing
Registration Number
NCT04390789
Lead Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
90
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
single visit retreatmentNon surgical Single visit Retreatmentnonsurgical root canal retreatment will be carried out in single visit.
multi visit retreatmentMulti visit Retreatment with calcium hydroxide dressingIn 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
Primary Outcome Measures
NameTimeMethod
Clinical and radiographic successBaseline to 1 year

Criteria 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 Outcome Measures
NameTimeMethod
Pain assessmentBaseline to 7days

Visual analogue scale (VAS) from 0 to 10 will be used to record preoperative and post -operative pain.

Trial Locations

Locations (2)

Sanjay Tewari

🇮🇳

Rohtak, Haryana, India

Post graduate institute of dental sciences

🇮🇳

Rohtak, Haryana, India

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