Impacted Third Molar ToothNCT05882162
Conventional Coronectomy vs Coronectomy in Combination Vital Pulp Treatment Using Calcium Silicate
A study testing Coronectomy and Pulp Capping with calcium silicate in people with Impacted Third Molar Tooth, run by zeynep cukurova yilmaz at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to compare the conventional coronectomy and the combined coronectomy technique with vital pulp treatment. The primary outcome of the study was to evaluate the success rates of two treatment techniques based on clinical and radiologic observations regarding inferior alveolar nerve injury, root… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- Coronectomy and Pulp Capping with calcium silicate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2018to 20 Apr 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - Patients without any systemic disorders
- Close relationship of the lower third molar and inferior alveolar nerve (IAN) on orthopantomography (OPTG) and Cone Beam Computed Tomography (CBCT)
- Pericoronitis around the third molar
- Caries presence or risk for caries development on the distal surface of adjacent second molar
- Follicle enlargement of less than 3 mm around the crown of the mandibular third molar on OPTG
- Teeth with complete apex development
Who cannot join
- -Presence of active infection (irreversible pulpitis) and/or pathology in the tooth
- In the presence of mobility in tooth
- Teeth with a horizontal position that are closely related to the IAN at the coronal portion
- Teeth undergoing resorption
- Smokers
- Patients who declined to take part in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Medipol University
Istanbul, Esenler, 34230
About this study
Official title: Conventional Coronectomy vs Coronectomy in Combination Vital Pulp Treatment Using Calcium Silicate ?: A Randomized Controlled Trial up to 1 Year
The aim of this study was to compare the conventional coronectomy and the combined coronectomy technique with vital pulp treatment. The primary outcome of the study was to evaluate the success rates of two treatment techniques based on clinical and radiologic observations regarding inferior alveolar nerve injury, root exposure and formation of periapical lesion. The secondary outcome was to evaluate the change in periodontal condition of the second molar adjacent to the operation area, dentin bridge formation and root migration.
Between March 2018 and February 2022 eligible patients attended University Hospital for the removal of lower third molar with risk of inferior alveolar nerve (IAN) damage invited to the study. 60 teeth meeting the inclusion criteria in 52 participants were randomized to Test (with BiodentineTM, n=30) and Control (without BiodentineTM, n=30) groups. Neurological injury and post-operative pain were clinically evaluated at 12th months and 1st week, respectively. Root migration, dentin bridge formation and periapical lesion development were evaluated using Cone Beam Computed Tomography (CBCT) at 12th month. The change in the periodontal status of second molar was evaluated by measurement of pocket depth at 1st, 3rd and 12th months and the distance between base of the bone defect and the marginal crest and cemento-enamel junction and at 6th and 12th months month.
Read the detailed description
The surgical removal of mandibular third molar teeth is one of the most frequently performed oral surgical procedures. One of the complications might occur during surgical removal of these teeth is injury to inferior alveolar nerve (IAN) which may lead to altered or loss of sensation to lower lip, chin, teeth and gingiva on the operated side. The risk for IAN injury may not be avoidable, even though the surgery was performed by an experienced surgeon and the positional relationship between the mandibular third molar and IAN was assessed accurately prior to surgery.
Pericoronitis, dental caries and periodontal disease are the most common pathologies associated with mandibular third molar teeth. Theoretically, removal of crown part of the teeth with a vital pulp and leaving the roots behind might be adequate to relive clinical symptoms arise from these pathologies. This technique was first described by Ecuyer and Debien in 1984 as coronectomy to prevent injury in case of close relationship of mandibular third molar with inferior IAN.
As shown previously in randomized clinical trials, fewer complications in terms of post-operative pain, IAN deficiency and dry socket were observed after coronectomy. Systematic reviews have confirmed that incidence of IAN injury was lower with coronectomy when compared to total removal in case of the lower third molar radiographically closely related with the IAN. Nerve injury was reported to occur in up to 20% of cases temporarily and 1-4% of cases permanently after total extraction, whereas 0-5.5% of cases temporarily after coronectomy.
Radiographic assessment using panaromic radiographs is the first step for coronectomy procedure. Presence of the interruption of the white line of the mandibular canal wall, darkening around the root(s), diverging of the mandibular canal, narrowing of the mandibular canal, narrowing of the root(s) and deflection of the root(s) are the indicators of increased risk for IAN injury. In recent years, cone beam computer tomography (CBCT) scanning is widely used method for further investigation to demonstrate the three-dimensional relationship between the tooth and IAN. Additionally, eligibility of the third molar for coronectomy should also be evaluated to be free of caries, pulpal inflammation and abnormal surrounding tissue. Coronectomy is contraindicated for non-compromised patients with good healing potential due to medical conditions such as diabetics, long-term steroid use, chemotherapy or radiotherapy.
One of the possible complications after coronectomy is migration and eruption of the roots left in the bone. Bone formation over the retained roots is expected to avoid eruption of these roots in the oral cavity. In case of eruption, remaining roots should be extracted. Another possible complication is periapical lesion development due to necrosis of the pulp. With conventional coronectomy procedure, no pulp treatment of the remaining roots is performed. Previous in vivo studies demonstrated that pulp retained vital after coronectomy. However, presence of pain and infection after coronectomy was reported in randomized clinical trials. Vital pulp treatment of the remaining roots with a bioactive material may have the potential to enhance both dentin and bone formation leading to reduced complications related with periapical inflammation and tooth migration.
In the literature, there is no study concerned with the clinical success of coronecyomy in combination with vital pulp treatment, except a case report. Therefore, the aim of this randomized clinical trial was to compare clinical success of conventional coronectomy and coronectomy in combination with vital pulp treatment based on clinical and radiologic evalutions. The null hypothesis tested in this study was that application of calcium silicate (Biodentine, Septodont, St Maur-des-Fosses, France) after coronectomy had no benefits to reduce above mentioned post-operative complications.
- Conditions
- Impacted Third Molar Tooth
- Being tested
- Coronectomy, Pulp Capping with calcium silicate
- Keywords
- coronectomy, vital pulp therapy, impacted third mandibular molar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoronectomyProcedure or surgery
Removal of crown part of the mandibular third molar
Pulp Capping with calcium silicateProcedure or surgery
Application of a pulp capping material (BiodentineTM, Septodont, St Maur-des-Fosses, France) on pulp tissue to preserve the vitality of the residual pulp and prevent inflammation
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | A scalpel number 15 was used to raise a triangular or envelope-shaped full-thickness mucoperiosteal flap. The bone in the buccal cavity of the third molar was removed with steel rounds and fissure burs to reach the cementum-enamel boundary. 3/4 of the tooth was cut bucco-lingually from 1-2 mm apical to the enamel cement border with the help of a high-speed surgical handpiece with a fissure steel bur. The root surface was positioned 2-3 mm apically from the surrounding alveolar bone level with the help of a steel round bur. The remaining enamel tissue and pulpal tissue in the coronal part were completely removed. Calcium silicate material was not used for pulp capping of the root pulp. During the procedure, the mandibular second molar's surface was curetted, and the surgical area was rinsed with saline solution to remove any potential surgical debris. The required number of simple sutures were used to close the surgical field without tension. Receives: Procedure: Coronectomy |
| Test Group | Experimental | A scalpel number 15 was used to raise a triangular or envelope-shaped full-thickness mucoperiosteal flap. The bone in the buccal cavity of the third molar was removed with steel rounds and fissure burs to reach the cementum-enamel boundary. 3/4 of the tooth was cut bucco-lingually from 1-2 mm apical to the enamel cement border with the help of a high-speed surgical handpiece with a fissure steel bur. The root surface was positioned 2-3 mm apically from the surrounding alveolar bone level with the help of a steel round bur. The remaining enamel tissue and pulpal tissue in the coronal part were completely removed. Calcium silicate material was used for pulp capping of the root pulp. During the procedure, the mandibular second molar's surface was curetted, and the surgical area was rinsed with saline solution to remove any potential surgical debris. The required number of simple sutures were used to close the surgical field without tension. Receives: Procedure: Coronectomy; Procedure: Pulp Capping with calcium silicate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of inferior alveolar nerve injury (yes/no)
Hypoesthesia/hyperesthesia/dysesthesia in the lower lip or mental region of the operated side were the clinical findings for nerve injury
Measured: 12 months
Root exposure (yes/no)
Total removal of the residual roots was required in case of eruption of the residual roots detected clinically
Measured: 12 months
Periapical lesion (yes/no)
Detection of periapical lesion due to necrosis of the residual root pulp radiographically (panoramic radiographs and CBCT) indicated failure of the treatment
Measured: 12 Months
Secondary outcomes (4)
Dentin bridge formation (yes/no)
Presence of dentin bridge formation at the coronal part of the root pulp indicated preservation of the vitality of the root pulp
Measured: 12 months
Pain (1-10)
Assessment of postoperative pain using a visual analog scale (VAS) printed on paper ranging from no pain to unbearable pain (1-10).
Measured: 1 week
Root migration (yes/no)
The movement of the residual roots after coronectomy evaluated by comparing the distance between the roots with and the inferior alveolar nerve radiographically. At baseline the roots of all of the third molars were close proximity with the inferior alveolar nerve.
Measured: 12 months
Maintenance of periodontal status of the adjacent tooth (yes/no)
Periodontal health of the second molar adjacent to operation site was evaluated according to measurement (milimeter) of probing pocket depth; the distance between base of the bone defect and the marginal crest and the distance between base of the bone defect and cemento-enamel junction. The measurements taken in the designated follow-ups were compared to baseline measurements to assess the change in the periodontal status.
Measured: 3,6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start20 Mar 2018
- Primary completion20 Feb 2022
- Study completion20 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Impacted Third Molar ToothStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- zeynep cukurova yilmaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, zeynep cukurova yilmaz, Istanbul Medipol University Hospital
- Investigators
- Zeynep Çukurova Yılmaz, DDS,PhD, Study director, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882162
- Sponsor's protocol ID
- 66291034-604.01.01-E.46464-17
- Status last verified
- Jun 2023
- First submitted
- 3 May 2023
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ali AS, Benton JA, Yates JM. Risk of inferior alveolar nerve injury with coronectomy vs surgical extraction of mandibular third molars-A comparison of two techniques and review of the literature. J Oral Rehabil. 2018 Mar;45(3):250-257. doi: 10.1111/joor.12589. Epub 2017 Dec 11.
PubMed 29171914Leung YY, Cheung LK. Safety of coronectomy versus excision of wisdom teeth: a randomized controlled trial. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Dec;108(6):821-7. doi: 10.1016/j.tripleo.2009.07.004. Epub 2009 Sep 26.
PubMed 19782621Renton 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 15620767Lopes V, Mumenya R, Feinmann C, Harris M. Third molar surgery: an audit of the indications for surgery, post-operative complaints and patient satisfaction. Br J Oral Maxillofac Surg. 1995 Feb;33(1):33-5. doi: 10.1016/0266-4356(95)90083-7.
PubMed 7718526Leung 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 26337212O'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 15356463Pitros P, O'Connor N, Tryfonos A, Lopes V. A systematic review of the complications of high-risk third molar removal and coronectomy: development of a decision tree model and preliminary health economic analysis to assist in treatment planning. Br J Oral Maxillofac Surg. 2020 Nov;58(9):e16-e24. doi: 10.1016/j.bjoms.2020.07.015. Epub 2020 Aug 14.
PubMed 32800608Long H, Zhou Y, Liao L, Pyakurel U, Wang Y, Lai W. Coronectomy vs. total removal for third molar extraction: a systematic review. J Dent Res. 2012 Jul;91(7):659-65. doi: 10.1177/0022034512449346. Epub 2012 May 23.
PubMed 22622663Kohara 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 25457826Monaco G, Vignudelli E, Diazzi M, Marchetti C, Corinaldesi G. Coronectomy of mandibular third molars: A clinical protocol to avoid inferior alveolar nerve injury. J Craniomaxillofac Surg. 2015 Oct;43(8):1694-9. doi: 10.1016/j.jcms.2015.07.006. Epub 2015 Jul 29.
PubMed 26321069Kouwenberg AJ, Stroy LP, Rijt ED, Mensink G, Gooris PJ. Coronectomy of the mandibular third molar: Respect for the inferior alveolar nerve. J Craniomaxillofac Surg. 2016 May;44(5):616-21. doi: 10.1016/j.jcms.2016.01.025. Epub 2016 Feb 18.
PubMed 26976696Tantanapornkul W, Okouchi K, Fujiwara Y, Yamashiro M, Maruoka Y, Ohbayashi N, Kurabayashi T. A comparative study of cone-beam computed tomography and conventional panoramic radiography in assessing the topographic relationship between the mandibular canal and impacted third molars. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Feb;103(2):253-9. doi: 10.1016/j.tripleo.2006.06.060. Epub 2006 Sep 1.
PubMed 17234544Gleeson CF, Patel V, Kwok J, Sproat C. Coronectomy practice. Paper 1. Technique and trouble-shooting. Br J Oral Maxillofac Surg. 2012 Dec;50(8):739-44. doi: 10.1016/j.bjoms.2012.01.001. Epub 2012 Jan 28.
PubMed 22285117Renton T. Update on coronectomy. A safer way to remove high risk mandibular third molars. Dent Update. 2013 Jun;40(5):362-4, 366-8. doi: 10.12968/denu.2013.40.5.362.
PubMed 23909229Pogrel MA, Lee JS, Muff DF. Coronectomy: a technique to protect the inferior alveolar nerve. J Oral Maxillofac Surg. 2004 Dec;62(12):1447-52. doi: 10.1016/j.joms.2004.08.003.
PubMed 15573343
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Coronectomy vs Coronectomy in Combination Vital Pulp Treatment Using Calcium Silicate ?: A Randomized Controlled Trial up to 1 Year
- ClinicalTrials.gov ID
- NCT05882162
- Acronym / sponsor ID
- 66291034-604.01.01-E.46464-17
- Conditions
- Impacted Third Molar Tooth
- Keywords
- coronectomy, vital pulp therapy, impacted third mandibular molar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- zeynep cukurova yilmazUniversity, hospital or other
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 20 Feb 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 31 May 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 aim of this study was to compare the conventional coronectomy and the combined coronectomy technique with vital pulp treatment. The primary outcome of the study was to evaluate the success rates of two treatment techniques based on clinical and radiologic observations regarding inferior alveolar nerve injury, root exposure and formation of periapical lesion. The secondary outcome was to evaluate the change in periodontal condition of the second molar adjacent to the operation area, dentin bridge formation and root migration.
Between March 2018 and February 2022 eligible patients attended University Hospital for the removal of lower third molar with risk of inferior alveolar nerve (IAN) damage invited to the study. 60 teeth meeting the inclusion criteria in 52 participants were randomized to Test (with BiodentineTM, n=30) and Control (without BiodentineTM, n=30) groups. Neurological injury and post-operative pain were clinically evaluated at 12th months and 1st week, respectively. Root migration, dentin bridge formation and periapical lesion development were evaluated using Cone Beam Computed Tomography (CBCT) at 12th month. The change in the periodontal status of second molar was evaluated by measurement of pocket depth at 1st, 3rd and 12th months and the distance between base of the bone defect and the marginal crest and cemento-enamel junction and at 6th and 12th months month.
Detailed description
The surgical removal of mandibular third molar teeth is one of the most frequently performed oral surgical procedures. One of the complications might occur during surgical removal of these teeth is injury to inferior alveolar nerve (IAN) which may lead to altered or loss of sensation to lower lip, chin, teeth and gingiva on the operated side. The risk for IAN injury may not be avoidable, even though the surgery was performed by an experienced surgeon and the positional relationship between the mandibular third molar and IAN was assessed accurately prior to surgery.
Pericoronitis, dental caries and periodontal disease are the most common pathologies associated with mandibular third molar teeth. Theoretically, removal of crown part of the teeth with a vital pulp and leaving the roots behind might be adequate to relive clinical symptoms arise from these pathologies. This technique was first described by Ecuyer and Debien in 1984 as coronectomy to prevent injury in case of close relationship of mandibular third molar with inferior IAN.
As shown previously in randomized clinical trials, fewer complications in terms of post-operative pain, IAN deficiency and dry socket were observed after coronectomy. Systematic reviews have confirmed that incidence of IAN injury was lower with coronectomy when compared to total removal in case of the lower third molar radiographically closely related with the IAN. Nerve injury was reported to occur in up to 20% of cases temporarily and 1-4% of cases permanently after total extraction, whereas 0-5.5% of cases temporarily after coronectomy.
Radiographic assessment using panaromic radiographs is the first step for coronectomy procedure. Presence of the interruption of the white line of the mandibular canal wall, darkening around the root(s), diverging of the mandibular canal, narrowing of the mandibular canal, narrowing of the root(s) and deflection of the root(s) are the indicators of increased risk for IAN injury. In recent years, cone beam computer tomography (CBCT) scanning is widely used method for further investigation to demonstrate the three-dimensional relationship between the tooth and IAN. Additionally, eligibility of the third molar for coronectomy should also be evaluated to be free of caries, pulpal inflammation and abnormal surrounding tissue. Coronectomy is contraindicated for non-compromised patients with good healing potential due to medical conditions such as diabetics, long-term steroid use, chemotherapy or radiotherapy.
One of the possible complications after coronectomy is migration and eruption of the roots left in the bone. Bone formation over the retained roots is expected to avoid eruption of these roots in the oral cavity. In case of eruption, remaining roots should be extracted. Another possible complication is periapical lesion development due to necrosis of the pulp. With conventional coronectomy procedure, no pulp treatment of the remaining roots is performed. Previous in vivo studies demonstrated that pulp retained vital after coronectomy. However, presence of pain and infection after coronectomy was reported in randomized clinical trials. Vital pulp treatment of the remaining roots with a bioactive material may have the potential to enhance both dentin and bone formation leading to reduced complications related with periapical inflammation and tooth migration.
In the literature, there is no study concerned with the clinical success of coronecyomy in combination with vital pulp treatment, except a case report. Therefore, the aim of this randomized clinical trial was to compare clinical success of conventional coronectomy and coronectomy in combination with vital pulp treatment based on clinical and radiologic evalutions. The null hypothesis tested in this study was that application of calcium silicate (Biodentine, Septodont, St Maur-des-Fosses, France) after coronectomy had no benefits to reduce above mentioned post-operative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: CoronectomyA scalpel number 15 was used to raise a triangular or envelope-shaped full-thickness mucoperiosteal flap. The bone in the buccal cavity of the third molar was removed with steel rounds and fissure burs to reach the cementum-enamel boundary. 3/4 of the tooth was cut bucco-lingually from 1-2 mm apical to the enamel cement border with the help of a high-speed surgical handpiece with a fissure steel bur. The root surface was positioned 2-3 mm apically from the surrounding alveolar bone level with the help of a steel round bur. The remaining enamel tissue and pulpal tissue in the coronal part were completely removed. Calcium silicate material was not used for pulp capping of the root pulp. During the procedure, the mandibular second molar's surface was curetted, and the surgical area was rinsed with saline solution to remove any potential surgical debris. The required number of simple sutures were used to close the surgical field without tension. |
| Test Group | Experimental | Procedure: Coronectomy, Procedure: Pulp Capping with calcium silicateA scalpel number 15 was used to raise a triangular or envelope-shaped full-thickness mucoperiosteal flap. The bone in the buccal cavity of the third molar was removed with steel rounds and fissure burs to reach the cementum-enamel boundary. 3/4 of the tooth was cut bucco-lingually from 1-2 mm apical to the enamel cement border with the help of a high-speed surgical handpiece with a fissure steel bur. The root surface was positioned 2-3 mm apically from the surrounding alveolar bone level with the help of a steel round bur. The remaining enamel tissue and pulpal tissue in the coronal part were completely removed. Calcium silicate material was used for pulp capping of the root pulp. During the procedure, the mandibular second molar's surface was curetted, and the surgical area was rinsed with saline solution to remove any potential surgical debris. The required number of simple sutures were used to close the surgical field without tension. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- - Patients without any systemic disorders
- Close relationship of the lower third molar and inferior alveolar nerve (IAN) on orthopantomography (OPTG) and Cone Beam Computed Tomography (CBCT)
- Pericoronitis around the third molar
- Caries presence or risk for caries development on the distal surface of adjacent second molar
- Follicle enlargement of less than 3 mm around the crown of the mandibular third molar on OPTG
Key exclusion criteria (6 listed)
- -Presence of active infection (irreversible pulpitis) and/or pathology in the tooth
- In the presence of mobility in tooth
- Teeth with a horizontal position that are closely related to the IAN at the coronal portion
- Teeth undergoing resorption
- Smokers
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 |
|---|---|---|
| CoronectomyRemoval of crown part of the mandibular third molar | Procedure or surgery | Control Group, Test Group |
| Pulp Capping with calcium silicateApplication of a pulp capping material (BiodentineTM, Septodont, St Maur-des-Fosses, France) on pulp tissue to preserve the vitality of the residual pulp and prevent inflammation | Procedure or surgery | Test Group |
Primary outcome
Presence of inferior alveolar nerve injury (yes/no)
Time frame: 12 months
Hypoesthesia/hyperesthesia/dysesthesia in the lower lip or mental region of the operated side were the clinical findings for nerve injury
Root exposure (yes/no)
Time frame: 12 months
Total removal of the residual roots was required in case of eruption of the residual roots detected clinically
Periapical lesion (yes/no)
Time frame: 12 Months
Detection of periapical lesion due to necrosis of the residual root pulp radiographically (panoramic radiographs and CBCT) indicated failure of the treatment
4 secondary outcomes
Dentin bridge formation (yes/no)
Time frame: 12 months
Pain (1-10)
Time frame: 1 week
Root migration (yes/no)
Time frame: 12 months
Maintenance of periodontal status of the adjacent tooth (yes/no)
Time frame: 3,6 and 12 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 6 Jun 2023.
- Background: PubMed 29171914Ali AS, Benton JA, Yates JM. Risk of inferior alveolar nerve injury with coronectomy vs surgical extraction of mandibular third molars-A comparison of two techniques and review of the literature. J Oral Rehabil. 2018 Mar;45(3):250-257. doi: 10.1111/joor.12589. Epub 2017 Dec 11.
- Background: PubMed 19782621Leung YY, Cheung LK. Safety of coronectomy versus excision of wisdom teeth: a randomized controlled trial. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Dec;108(6):821-7. doi: 10.1016/j.tripleo.2009.07.004. Epub 2009 Sep 26.
- 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.
- Background: PubMed 7718526Lopes V, Mumenya R, Feinmann C, Harris M. Third molar surgery: an audit of the indications for surgery, post-operative complaints and patient satisfaction. Br J Oral Maxillofac Surg. 1995 Feb;33(1):33-5. doi: 10.1016/0266-4356(95)90083-7.
- 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 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 32800608Pitros P, O'Connor N, Tryfonos A, Lopes V. A systematic review of the complications of high-risk third molar removal and coronectomy: development of a decision tree model and preliminary health economic analysis to assist in treatment planning. Br J Oral Maxillofac Surg. 2020 Nov;58(9):e16-e24. doi: 10.1016/j.bjoms.2020.07.015. Epub 2020 Aug 14.
- Background: PubMed 22622663Long H, Zhou Y, Liao L, Pyakurel U, Wang Y, Lai W. Coronectomy vs. total removal for third molar extraction: a systematic review. J Dent Res. 2012 Jul;91(7):659-65. doi: 10.1177/0022034512449346. Epub 2012 May 23.
- Background: PubMed 25457826Kohara 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.
- Background: PubMed 26321069Monaco G, Vignudelli E, Diazzi M, Marchetti C, Corinaldesi G. Coronectomy of mandibular third molars: A clinical protocol to avoid inferior alveolar nerve injury. J Craniomaxillofac Surg. 2015 Oct;43(8):1694-9. doi: 10.1016/j.jcms.2015.07.006. Epub 2015 Jul 29.
- Background: PubMed 26976696Kouwenberg AJ, Stroy LP, Rijt ED, Mensink G, Gooris PJ. Coronectomy of the mandibular third molar: Respect for the inferior alveolar nerve. J Craniomaxillofac Surg. 2016 May;44(5):616-21. doi: 10.1016/j.jcms.2016.01.025. Epub 2016 Feb 18.
- Background: PubMed 17234544Tantanapornkul W, Okouchi K, Fujiwara Y, Yamashiro M, Maruoka Y, Ohbayashi N, Kurabayashi T. A comparative study of cone-beam computed tomography and conventional panoramic radiography in assessing the topographic relationship between the mandibular canal and impacted third molars. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Feb;103(2):253-9. doi: 10.1016/j.tripleo.2006.06.060. Epub 2006 Sep 1.
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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.
Zeynep Çukurova Yılmaz, DDS,PhD study director
Private Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronectomy and Pulp Capping with calcium silicate in people with Impacted Third Molar Tooth, run by zeynep cukurova yilmaz at 1 site in Turkey (Türkiye).
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 6 inclusion and 6 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 6 Jun 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 Turkey (Türkiye). 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?
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?
Presence of inferior alveolar nerve injury (yes/no) (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT05882162, which also lists 20 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 6 Jun 2023.