Dentinal LossNCT06484218
Guided Endodontics Compared to Conventional Endodontic Treatment in Calcified Lower Incisors
A study testing conventional endodontic treatment and Guided endodontic treatment in people with Dentinal Loss, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
The dental pulp is a vital tissue that can be prone to physiological or pathological changes. Denticles, pulp stones, or other calcifications are frequently observed within "healthy" pulps. However, these tissue alterations can complicate the endodontic treatment. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dentinal Loss
- What is being tested?
- conventional endodontic treatment and Guided endodontic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jul 2023to 1 Apr 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Single-rooted mandibular incisor.
- Pulp canal obliteration extended from the cementoenamel junction more than five millimeters to the radicular pulp canal space.
- Vertucci type 1 classification.
- Teeth needing endodontic intervention: symptomatic tooth, peri-radicular lesion or endodontic-periodontic lesion.
- Straight root canal: curvature less than five degrees.
- No mobility.
Who cannot join
- Mandibular incisor with two roots.
- Teeth treated with a crown.
- Severely carious teeth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Guided Endodontics Compared to Conventional Endodontic Treatment in Calcified Lower Incisors: a Comparative in Vivo Pilot Study.
The dental pulp is a vital tissue that can be prone to physiological or pathological changes. Denticles, pulp stones, or other calcifications are frequently observed within "healthy" pulps. However, these tissue alterations can complicate the endodontic treatment. According to the American Association of Endodontists, teeth exhibiting "pulpal obliteration" fall into the moderate to high difficulty category of treatments, and their failure rate ranges from 10 to 19 per cent 1,2. In fact, pulpal calcification alone is not a reason for endodontic treatment. Root canal treatment is recommended and deemed necessary only in the presence of peri-radicular pathology or if the affected tooth shows symptoms. Today's techniques and materials offer higher standards, resulting in better root canal treatments and allowing proper handling of procedural errors. One of these materials is Cone beam computed tomography (CBCT) which is more reliable in detecting periapical lesions compared with digital periapical radiographs 3,visual aids, and ultrasonics 1. However, when performed by a non-experienced dentist, the risk of perforations, missed canals, stripping, and ledges arises 2. For the treatment of these challenging instances, the development of guided endodontics with a trephination guide, a metal sleeve, and an appropriate drill might be of interest 4. With several in vitro studies 5-7 and case reports 8,9 being published each year, this approach is becoming more prevalent in the literature. Additionally, a new endodontic guide software is being used to build new shapes for guides, sleeves, and drills, which will make it easier to attain correct access using the guiding technique. However, there is no information regarding the detection and negotiation of root canals, the dental substance loss, the treatment duration using the guided technique compared to the conventional technique for root canal treatments (RCTs) in clinical practice 10. This study is conducted to compare the conventional endodontic treatment to the guided approach in lower incisors with calcified root canals by focusing on the following aspects: the detection and negotiation of canals, the amount of substance loss, and the treatment duration.
Read the detailed description
Seven patients having two calcified lower incisors requiring root canal treatment were selected. For each patient, one incisor was treated with the CET while the other incisor was treated with the GET by a single operator, a graduate endodontic resident. The intracanal space of the treated teeth was volumetrically measured and compared using the indirect post core technique and Blenderfordental software (version 3.3 lts). The time was recorded from the start of the treatment until the root canal was negotiated to determine the treatment duration. Various statistical tests including BM SPSS Statistics software version 25.0 and the Wilcoxon signed rank test were used to identify potential significant differences between the CET and the GET in terms of volume and treatment duration with a significance threshold set at p < 0.05.
- Conditions
- Dentinal Loss
- Being tested
- conventional endodontic treatment, Guided endodontic treatment
- Keywords
- Lower incisors, pulp canal calcification, guided endodontics, dentinal loss, treatment duration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional endodontic treatmentProcedure or surgery
The conventional access cavity was prepared under the microscope through the incisal edge as this approach facilitates straight-line access. A high-speed contra-angle handpiece, associated with a long surgical bur 010 (Meisinger, CO, USA), was used until the dentin was exposed, which is in general 3 to 4 millimeters from the incisal edge. Then, the ultrasonic tip ED5 (woodpecker-DTE, Guilin, China) was marked with a stopper according to the calcification level viewed on the preoperative CBCT and then used gently at the stopper level until the canal was found.
Guided endodontic treatmentProcedure or surgery
In all cases, digital and clinical protocols were followed according to the method reported by Zehnder et al. and Connert et al. The guide was replaced, and the access cavity precisely drilled using the EG6 drill, mounted on a low-speed contra-angle handpiece. With every 3 mm of progression, the cavity was rinsed, and the head of the bur was cleaned until reaching the canal. The irrigation was done to avoid overheating the dentine and the accumulation of dentine debris
| Study group | Role | What they receive |
|---|---|---|
| Group CET | Experimental | The CET presented the conventional endodontic technique where one incisor was treated under microscope with an ultrasonic tip. Receives: Procedure: conventional endodontic treatment; Procedure: Guided endodontic treatment |
| Group GET | Active comparator | The GET presented the guided endodontic technique where one incisor was treated with a surgical guide. Receives: Procedure: conventional endodontic treatment; Procedure: Guided endodontic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of dental substance loss
Regarding the substance loss, the CET resulted in higher intracanal volume compared to the GET (7.8±3.3 mm3 vs 5.3±1.3 mm3, p=0.018).
Measured: 24 hours
the detection and negotiation of canals
Seven teeth were treated using the CET (n=7) and another seven using the GET (n=7). All teeth had negotiable canals except for one which was treated using the CET having the calcification level at the third third level of the middle part. . This unsuccessful case was referred to microsurgery treatment.
Measured: 24 hours
the treatment duration
the CET presented a significantly higher TD compared to the GET (69.0±57.4 mins vs 14.1±8.2 mins; p=0.018).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jul 2023
- Primary completion1 Oct 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentinal LossStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484218
- Sponsor's protocol ID
- USJ-2023-214
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Endodontics Compared to Conventional Endodontic Treatment in Calcified Lower Incisors: a Comparative in Vivo Pilot Study.
- ClinicalTrials.gov ID
- NCT06484218
- Acronym / sponsor ID
- USJ-2023-214
- Conditions
- Dentinal Loss
- Keywords
- Lower incisors, pulp canal calcification, guided endodontics, dentinal loss, treatment duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 3 Jul 2024 (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 dental pulp is a vital tissue that can be prone to physiological or pathological changes. Denticles, pulp stones, or other calcifications are frequently observed within "healthy" pulps. However, these tissue alterations can complicate the endodontic treatment. According to the American Association of Endodontists, teeth exhibiting "pulpal obliteration" fall into the moderate to high difficulty category of treatments, and their failure rate ranges from 10 to 19 per cent 1,2. In fact, pulpal calcification alone is not a reason for endodontic treatment. Root canal treatment is recommended and deemed necessary only in the presence of peri-radicular pathology or if the affected tooth shows symptoms. Today's techniques and materials offer higher standards, resulting in better root canal treatments and allowing proper handling of procedural errors. One of these materials is Cone beam computed tomography (CBCT) which is more reliable in detecting periapical lesions compared with digital periapical radiographs 3,visual aids, and ultrasonics 1. However, when performed by a non-experienced dentist, the risk of perforations, missed canals, stripping, and ledges arises 2. For the treatment of these challenging instances, the development of guided endodontics with a trephination guide, a metal sleeve, and an appropriate drill might be of interest 4. With several in vitro studies 5-7 and case reports 8,9 being published each year, this approach is becoming more prevalent in the literature. Additionally, a new endodontic guide software is being used to build new shapes for guides, sleeves, and drills, which will make it easier to attain correct access using the guiding technique. However, there is no information regarding the detection and negotiation of root canals, the dental substance loss, the treatment duration using the guided technique compared to the conventional technique for root canal treatments (RCTs) in clinical practice 10. This study is conducted to compare the conventional endodontic treatment to the guided approach in lower incisors with calcified root canals by focusing on the following aspects: the detection and negotiation of canals, the amount of substance loss, and the treatment duration.
Detailed description
Seven patients having two calcified lower incisors requiring root canal treatment were selected. For each patient, one incisor was treated with the CET while the other incisor was treated with the GET by a single operator, a graduate endodontic resident. The intracanal space of the treated teeth was volumetrically measured and compared using the indirect post core technique and Blenderfordental software (version 3.3 lts). The time was recorded from the start of the treatment until the root canal was negotiated to determine the treatment duration. Various statistical tests including BM SPSS Statistics software version 25.0 and the Wilcoxon signed rank test were used to identify potential significant differences between the CET and the GET in terms of volume and treatment duration with a significance threshold set at p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group CET | Experimental | Procedure: conventional endodontic treatment, Procedure: Guided endodontic treatmentThe CET presented the conventional endodontic technique where one incisor was treated under microscope with an ultrasonic tip. |
| Group GET | Active comparator | Procedure: conventional endodontic treatment, Procedure: Guided endodontic treatmentThe GET presented the guided endodontic technique where one incisor was treated with a surgical guide. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Single-rooted mandibular incisor.
- Pulp canal obliteration extended from the cementoenamel junction more than five millimeters to the radicular pulp canal space.
- Vertucci type 1 classification.
- Teeth needing endodontic intervention: symptomatic tooth, peri-radicular lesion or endodontic-periodontic lesion.
- Straight root canal: curvature less than five degrees.
Key exclusion criteria (3 listed)
- Mandibular incisor with two roots.
- Teeth treated with a crown.
- Severely carious teeth.
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 |
|---|---|---|
| conventional endodontic treatmentThe conventional access cavity was prepared under the microscope through the incisal edge as this approach facilitates straight-line access. A high-speed contra-angle handpiece, associated with a long surgical bur 010 (Meisinger, CO, USA), was used until the dentin was exposed, which is in general 3 to 4 millimeters from the incisal edge. Then, the ultrasonic tip ED5 (woodpecker-DTE, Guilin, China) was marked with a stopper according to the calcification level viewed on the preoperative CBCT and then used gently at the stopper level until the canal was found. | Procedure or surgery | Group CET, Group GET |
| Guided endodontic treatmentIn all cases, digital and clinical protocols were followed according to the method reported by Zehnder et al. and Connert et al. The guide was replaced, and the access cavity precisely drilled using the EG6 drill, mounted on a low-speed contra-angle handpiece. With every 3 mm of progression, the cavity was rinsed, and the head of the bur was cleaned until reaching the canal. The irrigation was done to avoid overheating the dentine and the accumulation of dentine debris | Procedure or surgery | Group CET, Group GET |
Primary outcome
Amount of dental substance loss
Time frame: 24 hours
Regarding the substance loss, the CET resulted in higher intracanal volume compared to the GET (7.8±3.3 mm3 vs 5.3±1.3 mm3, p=0.018).
the detection and negotiation of canals
Time frame: 24 hours
Seven teeth were treated using the CET (n=7) and another seven using the GET (n=7). All teeth had negotiable canals except for one which was treated using the CET having the calcification level at the third third level of the middle part. . This unsuccessful case was referred to microsurgery treatment.
the treatment duration
Time frame: 24 hours
the CET presented a significantly higher TD compared to the GET (69.0±57.4 mins vs 14.1±8.2 mins; p=0.018).
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 3 Jul 2024.
- Individual participant dataSharing planned: No
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 conventional endodontic treatment and Guided endodontic treatment in people with Dentinal Loss, run by Saint-Joseph University at 1 site in Lebanon.
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 3 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 3 Jul 2024. 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 Lebanon. 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?
Amount of dental substance loss (time frame: 24 hours). 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?
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 3 Jul 2024.