Guided Endodontics Compared to Conventional Endodontic Treatment in Calcified Lower Incisors

NCT06484218 | Completed

• 1 other identifier: USJ-2023-214
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dentinal Loss

Keywords

Lower incisors; pulp canal calcification; guided endodontics; dentinal loss; treatment duration

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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).

  24 hours

Study Arms (2)

Group CET

EXPERIMENTAL

The CET presented the conventional endodontic technique where one incisor was treated under microscope with an ultrasonic tip.

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.

Procedure: conventional endodontic treatment; Procedure: Guided endodontic treatment

Interventions

conventional endodontic treatment PROCEDURE

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.

Group CET; Group GET

Guided endodontic treatment PROCEDURE

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

Group CET; Group GET

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Mandibular incisor with two roots.
• Teeth treated with a crown.
• Severely carious teeth.

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint Joseph University

Beirut, Lebanon

Location

Study Design

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

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 3, 2024
• Study Start: July 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: April 1, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)