Non Vital TeethNCT07808424
To Evaluate and Compare the Effect of Orthograde and Retrograde MTA Root End Filling After Periapical Surgery in Posteriors
A study testing Endodontic Micro-Surgery in people with Non Vital Teeth and Persistent Symptomatic Apical Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Non Vital Teeth, Persistent Symptomatic Apical Periodontitis
- What is being tested?
- Endodontic Micro-Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteIndia
- Study dates
- 29 Apr 2026to 28 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
PGIDS
Rohtak, Haryana, 124001
Dr Shweta Mittal, MDS, 9255596960, shwetagoelendo@gmail.com
Vinita Vinita, PG Student, 8708666510, vinitabibyan51@yahoo.com
About this study
Official title: 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
Read the 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
- Being tested
- Endodontic Micro-Surgery
- Keywords
- persistant symptomatic apical periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endodontic Micro-SurgeryProcedure or 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-SurgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Endodontic Micro-Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Base line to 12 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline and at 24 hours, Day1, Day2, Day3, Day4, Day5, Day6 and Day7 after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start29 Apr 2026
- Primary completion28 Oct 2027 (estimated)
- Study completion28 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Non Vital TeethStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808424
- Sponsor's protocol ID
- Vinita
- Status last verified
- Sep 2026
- First submitted
- 22 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35871899Shugars 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.
PubMed 8957118Slade 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.
PubMed 9332805Del 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.
PubMed 19220513Moradi 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.
PubMed 25584057Stundzia 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.
PubMed 41377171Zheng 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.
PubMed 38297251Harinkhere 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.
PubMed 37632561
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07808424
- Acronym / sponsor ID
- Vinita
- Keywords
- persistant symptomatic apical periodontitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- 28 Oct 2027 (estimated)
- Study completion
- 28 Oct 2027 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with persistant symptomatic apical periodontitis with orthograde MTA plug | Experimental | Procedure: Endodontic Micro-SurgeryProcedure/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. |
| patients with persistant symptomatic apical periodontitis with conventional retrograde surgery | Active comparator | Procedure: Endodontic Micro-SurgeryProcedure/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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (5 listed)
- • Patients with systemic diseases (diabetes mellitus, uncontrolled hypertension grade III, hepatic/renal disease, or systemic bleeding disorders) (Bharathi et al 2021).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endodontic Micro-SurgeryProcedure/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 or surgery | patients with persistant symptomatic apical periodontitis with conventional retrograde surgery, patients with persistant symptomatic apical periodontitis with orthograde MTA plug |
| Endodontic Micro-SurgeryPatients 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 or surgery | patients with persistant symptomatic apical periodontitis with conventional retrograde surgery, patients with persistant symptomatic apical periodontitis with orthograde MTA plug |
Primary outcome
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.
2 secondary outcomes
Post operative pain
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Results publication: PubMed 35871899Wong 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.
- Results publication: PubMed 8957118Shugars 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.
- Results publication: PubMed 9332805Slade 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.
- Results publication: PubMed 19220513Del 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.
- Results publication: PubMed 25584057Moradi 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.
- Results publication: PubMed 41377171Stundzia 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.
- Results publication: PubMed 38297251Zheng 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.
- Results publication: PubMed 37632561Harinkhere 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endodontic Micro-Surgery in people with Non Vital Teeth and Persistent Symptomatic Apical Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. SHWETA MITTAL, MDS (9255596960, shwetagoelendo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periapical healing assessment (time frame: Base line to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07808424, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.