Health Trials

To Evaluate and Compare the Effect of Orthograde and Retrograde MTA Root End Filling After Periapical Surgery in Posteriors

ConditionsNon Vital TeethPersistent Symptomatic Apical Periodontitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorPostgraduate Institute of Dental Sciences Rohtak

About this trial

To evaluate and compare the effect of orthograde and retrograde MTA root end filling on clinical, 2D and 3D radiographic success and quality of life after periapical surgery in posteriors- A Randomised Control Trial

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients in which non-surgical retreatment is unfeasible (anatomical complexity, iatrogenic errors) or previously failed treatment in cases of persistent symptomatic apical periodontitis involving posteriors.

Tooth with a peri-radicular lesion of endodontic origin (chronic apical periodontitis) or endo-perio origin with the size of lesion ≥5mm.

Teeth with less than 10 degree root curvature.

Patients between 18-55 years of age.

Disqualifiers

• Patients with systemic diseases (diabetes mellitus, uncontrolled hypertension grade III, hepatic/renal disease, or systemic bleeding disorders) (Bharathi et al 2021).

Patients on anticoagulant/ antiplatelet drugs.

Fractured/perforated teeth.

Presence of vertical root fracture.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endodontic Micro-Surgery

    Procedure/Surgery

    Procedure/Surgery: Endodontic Micro-Surgery Patients with non vital teeth with persistant symptomatic apical periodontitis with lesion size \>5 mm not responding to conventional endodontic treatment \& planned for apical surgery using conventional retrograde root end filling technique.

  • Endodontic Micro-Surgery

    Procedure/Surgery

    Patients with non vital teeth with persistant symptomatic apical periodontitis with lesion size \>5 mm not responding to conventional endodontic treatment \& planned for apical surgery using orthograde plug of 6-7 mm.

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: patients with persistant symptomatic apical periodontitis with orthograde MTA plugExperimental treatment 1 intervention
Group B: patients with persistant symptomatic apical periodontitis with conventional retrograde surgeryActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Periapical healing assessment

Periapical healing comparison in 2 groups with 2d healing using Rud and Molven et al. (1987) score 1 is for Complete healing, score 2 for Incomplete healing (scar tissue), score3: Uncertain healing and score 4: Unsatisfactory healing (failure) 3d healing outcome will be measured by modified PENN 3D criteria which has score 1 for Complete healing, score 2:Limited healing, score 3:Uncertain healing and score4:Unsatisfactory healing.

Time frame
Base line to 12 months

Secondary outcomes

1

Post operative pain

To assess incidence and intensity of pain postoperatively at every 12 hours till 7 days using Visual analogue scale of 0-100mm line. Score 0 means no pain and Score 100 means maximum pain.

Time frame
Base line to 12 months
2

OHRQoL assessment

OHIP-14 questionnaire will be used to assess the quality of life. It consists of questionnaire in seven dimensions: functional limitations, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap. It will be scored using Lickert scale: never=0, hardly ever=1, occasionally=2, fairly often=3 and very often=4. Total score will be calculated ranging from 0-56 with higher score denoting the worst OHRQoL.

Time frame
Baseline and at 24 hours, Day1, Day2, Day3, Day4, Day5, Day6 and Day7 after the treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Postgraduate Institute of Dental Sciences Rohtak

Lead sponsor

Source ClinicalTrials.gov
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