An interventional study of Endodontic Micro-Surgery and Endodontic Micro-Surgery in Non Vital Teeth and Persistent Symptomatic Apical Periodontitis, sponsored by Postgraduate Institute of Dental Sciences Rohtak. Recruiting at 1 site in India. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Postgraduate Institute of Dental Sciences Rohtak · Not applicable, Interventional, and Treatment
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
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
280 studies on the registry are indexed under Periapical Periodontitis; 79 are open to participants now.
This study's planned enrollment of 54 is close to the median of 60 across 245 interventional studies indexed under Periapical Periodontitis.
Browse Periapical Periodontitis studies →Postgraduate Institute of Dental Sciences Rohtak is the lead sponsor of 213 studies on the registry; 72 are open to participants now.
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Exclusion Criteria:
Patients with systemic diseases (diabetes mellitus, uncontrolled hypertension grade III, hepatic/renal disease, or systemic bleeding disorders) (Bharathi et al 2021).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
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
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
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
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