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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07808424
Enrollment
54
Registered
2026-09-08
Start date
2026-04-29
Completion date
2027-10-28
Last updated
2026-09-08

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

Conditions

Non Vital Teeth, Persistent Symptomatic Apical Periodontitis

Keywords

persistant symptomatic apical periodontitis

Brief summary

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

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

Interventions

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.

Sponsors

Postgraduate Institute of Dental Sciences Rohtak
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Periapical healing assessmentBase line to 12 monthsPeriapical 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.

Secondary

MeasureTime frameDescription
Post operative painBase line to 12 monthsTo 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.
OHRQoL assessmentBaseline and at 24 hours, Day1, Day2, Day3, Day4, Day5, Day6 and Day7 after the treatmentOHIP-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.

Countries

India

Contacts

CONTACTDr. SHWETA MITTAL, MDS
shwetagoelendo@gmail.com9255596960
CONTACTVinita Vinita, PG student
vinitabibyan51@yahoo.com8708666510

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026