Inferior Alveolar Nerve InjuriesNCT05744882
The Need Of Root Canal Treatment After Coronectomy In Mandibular Third Molars
A study testing coronectony and root canal treatment in people with Inferior Alveolar Nerve Injuries and Root Canal Treatment, run by Altamash Institute of Dental Medicine at 1 site in Pakistan.
Trial summary
The study included 24 patients with written and verbal consent Results with close proximity to IAN diagnosed based on radiographs and evaluation on the criteria of Howe, and Poyton were selected and divided into two groups by lottery method into coronectomy and coronectomy with root canal treatment following… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Inferior Alveolar Nerve Injuries, Root Canal Treatment, Paresthesia
- What is being tested?
- coronectony and root canal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2021to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- cooperative,
- no known uncontrolled medical conditions
- no history of radiotherapy in the head and neck region
Who cannot join
- not willing to participate
- history of uncontrolled medical condition
- sign of any local pathology
- history of radiotherapy in head and neck region
Trial locations and contacts
1 site in 1 country.
About this study
The study included 24 patients with written and verbal consent Results with close proximity to IAN diagnosed based on radiographs and evaluation on the criteria of Howe, and Poyton were selected and divided into two groups by lottery method into coronectomy and coronectomy with root canal treatment following coronectomy groups. Patients were re-evaluated on three weeks for complications and three months follow-ups for radiographic evaluations of root-fragment migration
Read the detailed description
The study enrolled 24 patients with written and verbal consent, out of which 15 were females and 9 were males aged between 18-30 years, with a mean age of males 24 ± 2.6 years and females 23.5 ± 2.8 years. Ethical approval was taken from the ethical review board of Altamash Institute of Dental Medicine with IRB No: AIDM/ERC/12/2022/04.
A total of 24 impacted mandibular teeth from 24 Patients with close proximity to IAN diagnosed based on radiographs and evaluation on the criteria of Howe and Poyton4 were selected for the purpose of this study. The timeline of the study was between January 2021 till January 2022.
The estimated sample size calculated for the study was 12 (6 participants in each group) which was raised to minimum of 24 (12 participants in each group). The calculations were performed using 12.5% as a proportion of infection in the control group and 87.5% as the proportion of infection in experimentation group from the study published by Sencimen et al.1 The software used for the sample size estimation was STATA 13.0 using "pearson's chi-squared test for two-samples proportions test". The following parameters were considered:
Alpha = 0.05 Power = 0.8 Delta = 0.75 Proportions of control group = 0.125 (12.5%) Proportions of Experimental group = 0.875 (87.5%) Considering the high lost to followup cases into account the sample size was raised to 24 participants with one tooth per individual. (ANNEXURE-I)
Patients were diagnosed and then referred to the Oral Maxillofacial department of Altamash Institute of Dental Medicine. Twenty-four patients with 24 impacted mandibular third molars were equally divided into a control group and a study group. Twelve patients in the study group had their root canal treatment after coronectomies while the other half, the control group only had their coronectomies done without any further procedure performed.
All the participants were equally divided into a control group and a study group by making them pick concealed envelopes containing a participant code for the participant allocation into groups. The experimental group contained twelve participants who had root canal treatment following coronectomies, while on the other hand, only coronectomies were performed in the rest of the participants without root canal treatment.
Patients who were willing and cooperative, along with no known uncontrolled medical conditions and no history of radiotherapy in the head and neck region, were included as a part of this research, while patients who showed resistance or were uncooperative, gave a history of uncontrolled medical condition, showed signs of local pathology or infection, history of radiotherapy in head and neck area were excluded from being included in the study.
All surgical procedures were performed under local anesthesia by the same surgeon. None of the patients were prescribed prophylactic antibiotics but were give a chlorhexidine mouth was a given before the procedure. Patients were prescribed post operative antibiotics with analgesics and thorough written instructions for proper wound care. A buccal approach for coronectomy was performed for all of them by the surgeon. Furthermore, all the endodontic treatment was performed by the same endodontist.
In the study group, the endodontist performed a pulpectomy and used a hypochlorite solution for irrigation of the canals. Finally, gutta-percha (GP) was used as a canal-filling material. All procedures performed by the endodontic followed the aseptic conditions and protocol.
The surgeon decided on a buccal approach with a three-cornered envelope incision resulting in a full thickness mucoperiosteal flap. The incision and eventually the flap was raised following the principles of incision and flap in order to promote a clean surgery leading to an uneventful and complication-free healing. The crown along the dental follicle was eliminated in addition to removing one-third of the root coronally.
The clinician decided on establishing a tilted or angled slope, the level of the slope descending lingually via buccal surface. This inclination resulted in a discrepancy of about 3-4mm in the levels of the corresponding root surfaces, consequence of which was a formation of a sharp edge on the buccal root surface. While the lingual root was 3-4mm below the lingual alveolar crest level. To compensate for the height, difference the buccal and lingual root surfaces, a reduction in the height of the buccal surface was performed in order to match with the lowered lingual root portion. Winding up the surgery with copious irrigation with saline followed by primary wound closure The mentioned step was carried out for both the study and the control group but in the in the study group, after removal of the pulp and biomechanical preparation, the canals were filled with GP. Multiple periapical radiographs were taken during endodontic procedure to ensure the correct filling of the canals and optimum filling till the apices.
More over the surgeon made a point to use a sharp bur for every operation in order to excise the crown without mobilizing the roots. In the control group the pulp was left in place. Follows up initially third week followed by sixth month were done with the help of panoramic radiograph.
- Conditions
- Inferior Alveolar Nerve Injuries, Root Canal Treatment, Paresthesia, Third Molar, Impacted Third Molar Tooth, Coronectomy
- Being tested
- coronectony, root canal treatment
- Medical subject headings
- Mandibular Nerve Injuries, Paresthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronectonyProcedure or surgery
Also called procedure
root canal treatment
root canal treatmentProcedure or surgery
Also called rct
root canal treatment
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | no further treatment provided after coronectomy Receives: Procedure: coronectony |
| Experimental Group | Active comparator | root canal treatment provided after the coronectomy procedure Receives: Procedure: coronectony; Procedure: root canal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection
Patients presenting with pain or swelling or both postoperatively within 3rd week to 3rd month of procedure. The the clinical presentation was confirmed by a clinician on clinical examination.
Measured: 3 months
Secondary outcomes (2)
Paresthesia
Patient presenting with history of numbness on any follow-up visit.
Measured: 3 months
Movement of remnant root fragment
Apical movement remenant root fragment measured perpendicularly from occlusal plane by conparing pre-operative OPG-radiograph and another one taken at 3 month follow-up.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Jan 2021
- Primary completion1 Jan 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Inferior Alveolar Nerve InjuriesStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altamash Institute of Dental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehan Ahmad, Altamash Institute of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744882
- Sponsor's protocol ID
- AIDM/ERC/12/2022/04
- Status last verified
- Feb 2023
- First submitted
- 25 Jan 2023
- Last updated
- 27 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Riordan BC. Coronectomy (intentional partial odontectomy of lower third molars). Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2004 Sep;98(3):274-80. doi: 10.1016/S1079210404000496.
PubMed 15356463Renton T, Hankins M, Sproate C, McGurk M. A randomised controlled clinical trial to compare the incidence of injury to the inferior alveolar nerve as a result of coronectomy and removal of mandibular third molars. Br J Oral Maxillofac Surg. 2005 Feb;43(1):7-12. doi: 10.1016/j.bjoms.2004.09.002.
PubMed 15620767Howe, G.L. and Poyton, H.G. (1960) Prevention of Damage to the Inferior Dental Nerve during the Extraction of Mandibular Third Molars. British Dental Journal, 109, 355-363.
MERRILL RG. DECOMPRESSION FOR INFERIOR ALVEOLAR NERVE INJURY. J Oral Surg Anesth Hosp Dent Serv. 1964 Jul;22:291-300. No abstract available.
PubMed 14155469Kubota S, Imai T, Nakazawa M, Uzawa N. Risk stratification against inferior alveolar nerve injury after lower third molar extraction by scoring on cone-beam computed tomography image. Odontology. 2020 Jan;108(1):124-132. doi: 10.1007/s10266-019-00438-2. Epub 2019 Jun 17.
PubMed 31209581Cilasun U, Yildirim T, Guzeldemir E, Pektas ZO. Coronectomy in patients with high risk of inferior alveolar nerve injury diagnosed by computed tomography. J Oral Maxillofac Surg. 2011 Jun;69(6):1557-61. doi: 10.1016/j.joms.2010.10.026. Epub 2011 Feb 1.
PubMed 21288616Monaco G, D'Ambrosio M, De Santis G, Vignudelli E, Gatto MRA, Corinaldesi G. Coronectomy: A Surgical Option for Impacted Third Molars in Close Proximity to the Inferior Alveolar Nerve-A 5-Year Follow-Up Study. J Oral Maxillofac Surg. 2019 Jun;77(6):1116-1124. doi: 10.1016/j.joms.2018.12.017. Epub 2018 Dec 31.
PubMed 30689961Leung YY, Cheung LK. Long-term morbidities of coronectomy on lower third molar. Oral Surg Oral Med Oral Pathol Oral Radiol. 2016 Jan;121(1):5-11. doi: 10.1016/j.oooo.2015.07.012. Epub 2015 Jul 22.
PubMed 26337212Pedersen MH, Bak J, Matzen LH, Hartlev J, Bindslev J, Schou S, Norholt SE. Coronectomy of mandibular third molars: a clinical and radiological study of 231 cases with a mean follow-up period of 5.7years. Int J Oral Maxillofac Surg. 2018 Dec;47(12):1596-1603. doi: 10.1016/j.ijom.2018.06.006. Epub 2018 Jul 14.
PubMed 30017572Dalle Carbonare M, Zavattini A, Duncan M, Williams M, Moody A. Injury to the inferior alveolar and lingual nerves in successful and failed coronectomies: systematic review. Br J Oral Maxillofac Surg. 2017 Nov;55(9):892-898. doi: 10.1016/j.bjoms.2017.09.006. Epub 2017 Oct 20.
PubMed 29061470Nishimoto RN, Moshman AT, Dodson TB, Beirne OR. Why Is Mandibular Third Molar Coronectomy Successful Without Concurrent Root Canal Treatment? J Oral Maxillofac Surg. 2020 Nov;78(11):1886-1891. doi: 10.1016/j.joms.2020.05.046. Epub 2020 Jun 11.
PubMed 32640205Valmaseda-Castellon E, Berini-Aytes L, Gay-Escoda C. Inferior alveolar nerve damage after lower third molar surgical extraction: a prospective study of 1117 surgical extractions. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2001 Oct;92(4):377-83. doi: 10.1067/moe.2001.118284.
PubMed 11598570Pitros P, Jackson I, O'Connor N. Coronectomy: a retrospective outcome study. Oral Maxillofac Surg. 2019 Dec;23(4):453-458. doi: 10.1007/s10006-019-00794-x. Epub 2019 Aug 27.
PubMed 31456131Frenkel B, Givol N, Shoshani Y. Coronectomy of the mandibular third molar: a retrospective study of 185 procedures and the decision to repeat the coronectomy in cases of failure. J Oral Maxillofac Surg. 2015 Apr;73(4):587-94. doi: 10.1016/j.joms.2014.10.011. Epub 2014 Oct 22.
PubMed 25544301Kohara K, Kurita K, Kuroiwa Y, Goto S, Umemura E. Usefulness of mandibular third molar coronectomy assessed through clinical evaluation over three years of follow-up. Int J Oral Maxillofac Surg. 2015 Feb;44(2):259-66. doi: 10.1016/j.ijom.2014.10.003. Epub 2014 Nov 8.
PubMed 25457826
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Need Of Root Canal Treatment After Coronectomy In Mandibular Third Molars
- ClinicalTrials.gov ID
- NCT05744882
- Acronym / sponsor ID
- AIDM/ERC/12/2022/04
- Conditions
- Inferior Alveolar Nerve Injuries, Root Canal Treatment, Paresthesia, Third Molar, Impacted Third Molar Tooth, Coronectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Altamash Institute of Dental MedicineUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 27 Feb 2023 (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.
The study included 24 patients with written and verbal consent Results with close proximity to IAN diagnosed based on radiographs and evaluation on the criteria of Howe, and Poyton were selected and divided into two groups by lottery method into coronectomy and coronectomy with root canal treatment following coronectomy groups. Patients were re-evaluated on three weeks for complications and three months follow-ups for radiographic evaluations of root-fragment migration
Detailed description
The study enrolled 24 patients with written and verbal consent, out of which 15 were females and 9 were males aged between 18-30 years, with a mean age of males 24 ± 2.6 years and females 23.5 ± 2.8 years. Ethical approval was taken from the ethical review board of Altamash Institute of Dental Medicine with IRB No: AIDM/ERC/12/2022/04.
A total of 24 impacted mandibular teeth from 24 Patients with close proximity to IAN diagnosed based on radiographs and evaluation on the criteria of Howe and Poyton4 were selected for the purpose of this study. The timeline of the study was between January 2021 till January 2022.
The estimated sample size calculated for the study was 12 (6 participants in each group) which was raised to minimum of 24 (12 participants in each group). The calculations were performed using 12.5% as a proportion of infection in the control group and 87.5% as the proportion of infection in experimentation group from the study published by Sencimen et al.1 The software used for the sample size estimation was STATA 13.0 using "pearson's chi-squared test for two-samples proportions test". The following parameters were considered:
Alpha = 0.05 Power = 0.8 Delta = 0.75 Proportions of control group = 0.125 (12.5%) Proportions of Experimental group = 0.875 (87.5%) Considering the high lost to followup cases into account the sample size was raised to 24 participants with one tooth per individual. (ANNEXURE-I)
Patients were diagnosed and then referred to the Oral Maxillofacial department of Altamash Institute of Dental Medicine. Twenty-four patients with 24 impacted mandibular third molars were equally divided into a control group and a study group. Twelve patients in the study group had their root canal treatment after coronectomies while the other half, the control group only had their coronectomies done without any further procedure performed.
All the participants were equally divided into a control group and a study group by making them pick concealed envelopes containing a participant code for the participant allocation into groups. The experimental group contained twelve participants who had root canal treatment following coronectomies, while on the other hand, only coronectomies were performed in the rest of the participants without root canal treatment.
Patients who were willing and cooperative, along with no known uncontrolled medical conditions and no history of radiotherapy in the head and neck region, were included as a part of this research, while patients who showed resistance or were uncooperative, gave a history of uncontrolled medical condition, showed signs of local pathology or infection, history of radiotherapy in head and neck area were excluded from being included in the study.
All surgical procedures were performed under local anesthesia by the same surgeon. None of the patients were prescribed prophylactic antibiotics but were give a chlorhexidine mouth was a given before the procedure. Patients were prescribed post operative antibiotics with analgesics and thorough written instructions for proper wound care. A buccal approach for coronectomy was performed for all of them by the surgeon. Furthermore, all the endodontic treatment was performed by the same endodontist.
In the study group, the endodontist performed a pulpectomy and used a hypochlorite solution for irrigation of the canals. Finally, gutta-percha (GP) was used as a canal-filling material. All procedures performed by the endodontic followed the aseptic conditions and protocol.
The surgeon decided on a buccal approach with a three-cornered envelope incision resulting in a full thickness mucoperiosteal flap. The incision and eventually the flap was raised following the principles of incision and flap in order to promote a clean surgery leading to an uneventful and complication-free healing. The crown along the dental follicle was eliminated in addition to removing one-third of the root coronally.
The clinician decided on establishing a tilted or angled slope, the level of the slope descending lingually via buccal surface. This inclination resulted in a discrepancy of about 3-4mm in the levels of the corresponding root surfaces, consequence of which was a formation of a sharp edge on the buccal root surface. While the lingual root was 3-4mm below the lingual alveolar crest level. To compensate for the height, difference the buccal and lingual root surfaces, a reduction in the height of the buccal surface was performed in order to match with the lowered lingual root portion. Winding up the surgery with copious irrigation with saline followed by primary wound closure The mentioned step was carried out for both the study and the control group but in the in the study group, after removal of the pulp and biomechanical preparation, the canals were filled with GP. Multiple periapical radiographs were taken during endodontic procedure to ensure the correct filling of the canals and optimum filling till the apices.
More over the surgeon made a point to use a sharp bur for every operation in order to excise the crown without mobilizing the roots. In the control group the pulp was left in place. Follows up initially third week followed by sixth month were done with the help of panoramic radiograph.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Procedure: coronectonyno further treatment provided after coronectomy |
| Experimental Group | Active comparator | Procedure: coronectony, Procedure: root canal treatmentroot canal treatment provided after the coronectomy procedure |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- cooperative,
- no known uncontrolled medical conditions
- no history of radiotherapy in the head and neck region
Key exclusion criteria (4 listed)
- not willing to participate
- history of uncontrolled medical condition
- sign of any local pathology
- history of radiotherapy in head and neck region
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 |
|---|---|---|
| coronectonyAlso: procedureroot canal treatment | Procedure or surgery | Control Group, Experimental Group |
| root canal treatmentAlso: rctroot canal treatment | Procedure or surgery | Experimental Group |
Primary outcome
Infection
Time frame: 3 months
Patients presenting with pain or swelling or both postoperatively within 3rd week to 3rd month of procedure. The the clinical presentation was confirmed by a clinician on clinical examination.
2 secondary outcomes
Paresthesia
Time frame: 3 months
Movement of remnant root fragment
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Background: PubMed 15356463O'Riordan BC. Coronectomy (intentional partial odontectomy of lower third molars). Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2004 Sep;98(3):274-80. doi: 10.1016/S1079210404000496.
- Background: PubMed 15620767Renton T, Hankins M, Sproate C, McGurk M. A randomised controlled clinical trial to compare the incidence of injury to the inferior alveolar nerve as a result of coronectomy and removal of mandibular third molars. Br J Oral Maxillofac Surg. 2005 Feb;43(1):7-12. doi: 10.1016/j.bjoms.2004.09.002.
- BackgroundHowe, G.L. and Poyton, H.G. (1960) Prevention of Damage to the Inferior Dental Nerve during the Extraction of Mandibular Third Molars. British Dental Journal, 109, 355-363.
- Background: PubMed 14155469MERRILL RG. DECOMPRESSION FOR INFERIOR ALVEOLAR NERVE INJURY. J Oral Surg Anesth Hosp Dent Serv. 1964 Jul;22:291-300. No abstract available.
- Background: PubMed 31209581Kubota S, Imai T, Nakazawa M, Uzawa N. Risk stratification against inferior alveolar nerve injury after lower third molar extraction by scoring on cone-beam computed tomography image. Odontology. 2020 Jan;108(1):124-132. doi: 10.1007/s10266-019-00438-2. Epub 2019 Jun 17.
- Background: PubMed 21288616Cilasun U, Yildirim T, Guzeldemir E, Pektas ZO. Coronectomy in patients with high risk of inferior alveolar nerve injury diagnosed by computed tomography. J Oral Maxillofac Surg. 2011 Jun;69(6):1557-61. doi: 10.1016/j.joms.2010.10.026. Epub 2011 Feb 1.
- Background: PubMed 30689961Monaco G, D'Ambrosio M, De Santis G, Vignudelli E, Gatto MRA, Corinaldesi G. Coronectomy: A Surgical Option for Impacted Third Molars in Close Proximity to the Inferior Alveolar Nerve-A 5-Year Follow-Up Study. J Oral Maxillofac Surg. 2019 Jun;77(6):1116-1124. doi: 10.1016/j.joms.2018.12.017. Epub 2018 Dec 31.
- Background: PubMed 26337212Leung YY, Cheung LK. Long-term morbidities of coronectomy on lower third molar. Oral Surg Oral Med Oral Pathol Oral Radiol. 2016 Jan;121(1):5-11. doi: 10.1016/j.oooo.2015.07.012. Epub 2015 Jul 22.
- Background: PubMed 30017572Pedersen MH, Bak J, Matzen LH, Hartlev J, Bindslev J, Schou S, Norholt SE. Coronectomy of mandibular third molars: a clinical and radiological study of 231 cases with a mean follow-up period of 5.7years. Int J Oral Maxillofac Surg. 2018 Dec;47(12):1596-1603. doi: 10.1016/j.ijom.2018.06.006. Epub 2018 Jul 14.
- Background: PubMed 29061470Dalle Carbonare M, Zavattini A, Duncan M, Williams M, Moody A. Injury to the inferior alveolar and lingual nerves in successful and failed coronectomies: systematic review. Br J Oral Maxillofac Surg. 2017 Nov;55(9):892-898. doi: 10.1016/j.bjoms.2017.09.006. Epub 2017 Oct 20.
- Background: PubMed 32640205Nishimoto RN, Moshman AT, Dodson TB, Beirne OR. Why Is Mandibular Third Molar Coronectomy Successful Without Concurrent Root Canal Treatment? J Oral Maxillofac Surg. 2020 Nov;78(11):1886-1891. doi: 10.1016/j.joms.2020.05.046. Epub 2020 Jun 11.
- Background: PubMed 11598570Valmaseda-Castellon E, Berini-Aytes L, Gay-Escoda C. Inferior alveolar nerve damage after lower third molar surgical extraction: a prospective study of 1117 surgical extractions. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2001 Oct;92(4):377-83. doi: 10.1067/moe.2001.118284.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coronectony and root canal treatment in people with Inferior Alveolar Nerve Injuries and Root Canal Treatment, run by Altamash Institute of Dental Medicine at 1 site in Pakistan.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 27 Feb 2023. 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 Pakistan. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection (time frame: 3 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 NCT05744882, which also lists 17 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 27 Feb 2023.