Removal of Intracanal Medicaments by Different Techniques Using Cone Beam Computed Tomography Analysis (Ca(OH)2 - CBCT)

"Removal of Intracanal Medicament by Different Techniques: (Cone Beam Computed Tomography Analysis) (Clinical Study)"

the goal of this study is to evaluate the efficency of different activation techniques in removal of intracanal medication using cone beam computed tomography analysis

Study Overview

• Status: Not yet recruiting
• Conditions: Removal of Intracanal Medication
• Intervention / Treatment: Procedure: Manual Dynamic Agitation; Procedure: Sonic Activation; Procedure: XP-Endo Finisher Activation

Detailed Description

the primary etiological factors for pulpal and periradicular diseases are microorganisms. Therefore, the primary purpose of endodontic treatment is to completely eradicate microorganisms from the root canal. This is achieved through chemo-mechanical preparation of the canal, which includes proper cleaning and shaping by instrumentation and irrigation.

Complexity of the root canal system compromises the eradication of microorganisms completely by traditional methods. The remaining bacteria may multiply between appointments and reach the same previous concentration. Therefore, intracanal medicaments play an important role in canal disinfection.

Intracanal medication becomes more necessary in cases involving bacteria that are resistant to routine treatment, as well as in situations where successful completion of therapy is hindered by persistent pain or continuous exudate.

The concept is to temporarily fill the root canal with a material that would chemically and physically enhance eradication and prevent the proliferation of microorganisms.

The most commonly used intracanal medicament is calcium hydroxide (Ca(OH)2), Through releasing hydroxyl ions disrupts the structural integrity of bacterial cytoplasmic membranes. In addition, Ca(OH)₂ indirectly affects anaerobic microorganisms within the root canal through a reaction between calcium ions and aqueous carbon dioxide, resulting in degradation of bacterial lipopolysaccharides.

Moreover, the biological properties of Ca(OH)₂ as antimicrobial action, induction of hard tissue deposition, and promotion of improved tissue repair all of this make that it considered as the material of choice of intracanal medicament.

However , despite its benefits, Ca (OH)₂ remnants on the canal walls showed multiple disadvantages such as; affecting sealer penetration into dentinal tubules, weakening their final bond to dentin and delaying the setting of some sealers such as zinc oxide eugenol so, Ca (OH)₂ remnants still one of the obstacles during complete the root canal obturation and interference with the physical properties of sealers has been shown to increase apical leakage and eventually compromise the outcome of endodontic treatment.

Additional disadvantages of Ca (OH)₂ include the challenge of removing it from the root canal walls and complete removal of it prior to final obturation is critical. However, manual irrigation alone was unable to completely remove intracanal medicament regardless of the agent use Numerous methods have been suggested for the removal of Ca (OH)₂ from the root canal such as : (1) Manual irrigation with a syringe (2) Manual dynamic agitation (3) Canal brush (4) Passive ultrasonic irrigation (5) Sonic irrigation (6) XP-shaper (7) XP-finisher (8) Rins Endo (9) Endo vac Numerous methods have been used to assess the amount of Ca (OH)₂ remnants within the root canal. These include digital photographs, stereomicroscopy, scanning electron microscopy, and micro-computed tomography.

However, the recent availability of cone beam computed tomography (CBCT) is considered an accurate, noninvasive imaging technique and has been employed to evaluate the quantity of residual intracanal calcium hydroxide. CBCT provides a three-dimensional volume measurement without the need to section the specimens Group assignment

Patients will be randomly divided into three equally treated groups (n=10) According to the type of activation technique as follow:

Group 1: Manual Dynamic Agitation (MDA)* Group 2: Sonic Activation† Group 3: XP-finisher activation‡

After intracanal medicament placement, the volume of the medicament will be measured using CBCT analysis software†††. The patient will then be recalled after one week[19]. At the recall visit, the tooth will be isolated and the intracanal medicament will be removed according to the assigned group:

Group 1: MDA Group 2: Sonic Activation Group3: XP-finisher activation Following intracanal medicament removal according to each group, a second CBCT scan will be taken for evaluation. CBCT interpretation will be used to detect the remnants of intracanal medicament and measure its volume using the cone-beam analysis software After image evaluation, the canal will be dried with sterile paper points, and root canal obturation will be performed using gutta-percha cone* and a resin-based sealer*, employing the cold lateral condensation technique.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mahmoud B Basuoni Aboseira, BDS; Phone Number: +21019469738; Email: PG_191164@dent.tanta.edu.eg

Study Locations

• Egypt
  • Gharbia Governorate
    • Tanta, Gharbia Governorate, Egypt, 31773
      • Faculty of Dentistry, Tanta University
      • Contact: Mahmoud B Basuoni Aboseira, BDS; Phone Number: +1019469738; Email: PG_194464@dent.tanta.edu.eg
      • Principal Investigator: Ahmed h labib, professor of endodontics
      • Sub-Investigator: Mohammed f Ali Mansour, lecturer of endodontics
      • Sub-Investigator: Mahmoud B Basuoni Aboseira, BDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Restorable mature non-vital single canal anterior tooth with or without signs of periapical pathosis.
2. Teeth without anatomical variations
3. Medically free patients

Exclusion Criteria:

1. Non-restorable tooth
2. Retreatment cases
3. Teeth with root fractures
4. Teeth with root resorption

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manual Dynamic Agitation (MDA); Removal of intracanal calcium hydroxide using manual dynamic agitation	Procedure: Manual Dynamic Agitation; Manual dynamic agitation was used for the removal of intracanal calcium hydroxide following standardized root canal preparation and irrigation.
Experimental: Sonic Activation; Removal of intracanal calcium hydroxide using sonic activation	Procedure: Sonic Activation; Sonic activation was used for the removal of intracanal calcium hydroxide following standardized root canal preparation and irrigation.
Experimental: XP-Endo Finisher Activation; Removal of intracanal calcium hydroxide using XP-Endo Finisher activation	Procedure: XP-Endo Finisher Activation; XP-Endo Finisher activation was used for the removal of intracanal calcium hydroxide following standardized root canal preparation and irrigation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of Remnants of Intracanal Calcium Hydroxide	The volume of remnants of intracanal calcium hydroxide after removal using the assigned activation technique, measured by cone beam computed tomography (CBCT).	1 week after intracanal medicament placement

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Ahmed H Labib, professor of endodontics, Faculty of Dentistry, Tanta University; Study Director: Mohammed F Ali Mansour, lecturer of endodontics, Faculty of Dentistry, Tanta University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: July 17, 2026
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: END/5-26/3587

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No