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

September 7, 2026 updated by: Postgraduate Institute of Dental Sciences Rohtak

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

RATIONALE:

Mineral Trioxide Aggregate (MTA) has long been established as a reliable material in retrograde filling techniques, with extensive evidence supporting its biocompatibility and sealing ability. However, the use of MTA as orthograde root end filling has not been explored, leaving a gap in clinical evidence. Retrograde placement allows direct visualization whereas orthograde filling offers a less invasive approach that could potentially reduce patient morbidity and improve comfort. Comparing these two techniques is essential to determine whether orthograde MTA filling can achieve comparable or superior healing outcomes while enhancing patient quality of life. This study aims to systematically assess both approaches, providing evidence-based insights that may guide clinicians toward more effective and patient-friendly treatment strategies.

Aim: 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

Primary objective: To evaluate and compare the effect of orthograde root end filling and retrograde root end filling on 2D and 3D radiographic and clinical healing at 1 year follow up

Secondary objective: To evaluate the quality of life after orthograde and retrograde root end filling

Setting: Study will be conducted in Post Graduate Institute of Dental Sciences, Rohtak in the department of Conservative Dentistry & Endodontics.

Study design: A randomized controlled trial

Time frame: 12Months

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.
  • No general medical contraindications for oral surgical procedures (ASA-1 according to the classification of the American Society of Anesthesiologists)
  • Tooth with adequate final restoration without clinical evidence of coronal leakage.
  • Good periodontal health condition at tooth level.
  • Able to completely understand and sign an informed consent form.

Exclusion Criteria:

  • • 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.
    • Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients with persistant symptomatic apical periodontitis with orthograde MTA plug
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 orthograde plug of 6-7 mm.
Procedure: Endodontic Micro-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.

Procedure: 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 orthograde plug of 6-7 mm.
Active Comparator: patients with persistant symptomatic apical periodontitis with conventional retrograde 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.
Procedure: Endodontic Micro-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.

Procedure: 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 orthograde plug of 6-7 mm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periapical healing assessment
Time Frame: Base line to 12 months
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.
Base line to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative pain
Time Frame: Base line to 12 months
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.
Base line to 12 months
OHRQoL assessment
Time Frame: Baseline and at 24 hours, Day1, Day2, Day3, Day4, Day5, Day6 and Day7 after the treatment
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.
Baseline and at 24 hours, Day1, Day2, Day3, Day4, Day5, Day6 and Day7 after the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Dental Sciences Rohtak

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2026

Primary Completion (Estimated)

October 28, 2027

Study Completion (Estimated)

October 28, 2027

Study Registration Dates

First Submitted

August 22, 2026

First Submitted That Met QC Criteria

September 7, 2026

First Posted (Actual)

September 8, 2026

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 7, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Vinita

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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