NCT07808424

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Apr 2026Oct 2027

Study Start

First participant enrolled

April 29, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2027

Last Updated

September 8, 2026

Status Verified

September 1, 2026

Enrollment Period

1.5 years

First QC Date

August 22, 2026

Last Update Submit

September 7, 2026

Conditions

Non Vital TeethPersistent Symptomatic Apical Periodontitis

Keywords

persistant symptomatic apical periodontitis

Outcome Measures

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.

    Base line to 12 months

Secondary Outcomes (2)

  • Post operative pain

    Base line to 12 months

  • OHRQoL assessment

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

Study Arms (2)

patients with persistant symptomatic apical periodontitis with orthograde MTA plug

EXPERIMENTAL

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

patients with persistant symptomatic apical periodontitis with conventional retrograde surgery

ACTIVE COMPARATOR

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

Interventions

Endodontic Micro-SurgeryPROCEDURE

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 persistant symptomatic apical periodontitis with conventional retrograde surgerypatients with persistant symptomatic apical periodontitis with orthograde MTA plug

Eligibility Criteria

Age18 Years - 55 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

RECRUITING

Related Publications (8)

  • Wong J, Cheung GSP, Lee AHC, McGrath C, Neelakantan P. PROMs Following Root Canal Treatment and Surgical Endodontic Treatment. Int Dent J. 2023 Feb;73(1):28-41. doi: 10.1016/j.identj.2022.06.015. Epub 2022 Jul 21.

    PMID: 35871899RESULT

  • Shugars DA, Benson K, White RP Jr, Simpson KN, Bader JD. Developing a measure of patient perceptions of short-term outcomes of third molar surgery. J Oral Maxillofac Surg. 1996 Dec;54(12):1402-8. doi: 10.1016/s0278-2391(96)90253-0.

    PMID: 8957118RESULT

  • Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.

    PMID: 9332805RESULT

  • Del Fabbro M, Taschieri S, Weinstein R. Quality of life after microscopic periradicular surgery using two different incision techniques: a randomized clinical study. Int Endod J. 2009 Apr;42(4):360-7. doi: 10.1111/j.1365-2591.2008.01534.x. Epub 2009 Feb 7.

    PMID: 19220513RESULT

  • Moradi S, Disfani R, Lomee M, Naghavi N. Effect of root resection on sealing ability of orthograde apical plugs of mineral trioxide aggregate and calcium enriched mixture. J Dent (Tehran). 2014 Jul;11(4):447-54. Epub 2014 Jul 31.

    PMID: 25584057RESULT

  • Stundzia L, Veberiene R, Graunaite I, Domeika A, Skucaite N. Retrograde Versus Orthograde Obturation in Relation to Root Resection: Evaluation of Microhardness of Mineral Trioxide Aggregate In Vitro. Int J Dent. 2025 Dec 2;2025:6647418. doi: 10.1155/ijod/6647418. eCollection 2025.

    PMID: 41377171RESULT

  • Zheng C, Wu W, Zhang Y, Tang Z, Xie Z, Chen Z. A novel simplified approach for endodontic retrograde surgery in short single-rooted teeth. BMC Oral Health. 2024 Jan 31;24(1):150. doi: 10.1186/s12903-024-03879-6.

    PMID: 38297251RESULT

  • Harinkhere C, Patni PM, Jain P, Raghuwanshi S, Pandey SH, Bilaiya S. Comparison of the sealing ability amongst orthograde apical plugs of mineral trioxide aggregate plus, mineral trioxide aggregate repair HP, and Biodentine after root resection: a bacterial leakage study. Odontology. 2024 Apr;112(2):364-371. doi: 10.1007/s10266-023-00847-4. Epub 2023 Aug 26.

    PMID: 37632561RESULT

Central Study Contacts

Dr. SHWETA MITTAL, MDS

CONTACT

9255596960shwetagoelendo@gmail.com

Vinita Vinita, PG student

CONTACT

8708666510vinitabibyan51@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2026

First Posted

September 8, 2026

Study Start

April 29, 2026

Primary Completion (Estimated)

October 28, 2027

Study Completion (Estimated)

October 28, 2027

Last Updated

September 8, 2026

Record last verified: 2026-09

Locations

IN(1)