Garlic Oil As Root Filling Material in Primary Molars

NCT06755502 | Not Yet Recruiting DMC

• 1 other identifier: 555
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to test garlic oil mixed with zinc oxide as a potential root canal filling material of primary molars in children aged from four to eight years. the study hypothesized that garlic oil mixed with zinc oxide would be the same as the gold standard filling material (metapex). The group receiving the garlic oil with zinc oxide as root canal filling material will be compared with other similar group receiving metapex as root canal filling material in terms of clinical and radio-graphic success, and working time.

Conditions

Irreversible Pulpitis (toothache)

Keywords

RCT; garlic oil; natural remedies; primary molars; root canal filling material

Outcome Measures

Primary Outcomes (2)

• The clinical success rate

  The criteria of successful treatment, according to which the clinical evaluation will be done, will be "No abnormal mobility", "No sensitivity to percussion", and "No swelling"

  3, 6,9,and 12 months

• Radio-graphic success

  For the radiographic success, the evaluation criteria will be "Preoperative pathological inter-radicular and/or periapical radiolucency started to resolve, or remained the same size", "No new postoperative pathological radiolucency developed", and "No pathological internal or external root resorption"

  6, and 12 month.

Study Arms (2)

garlic oil with zinc oxide group

EXPERIMENTAL

Combination Product: Garlic oil

metapex group

ACTIVE COMPARATOR

Drug: Calcium Hydroxide, Iodoform, paste

Interventions

Garlic oil COMBINATION_PRODUCT

garlic oil mixed with zinc oxid powder, as root canal filling material

garlic oil with zinc oxide group

Calcium Hydroxide, Iodoform, paste DRUG

Metapex as root canal filling materials

Also known as: metapex

metapex group

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Primary second molars which are diagnosed with irreversible pulpitis, or pulp necrosis.
• Presence of sinus tract.
• Periapical bone swelling.
• Continuous bleeding after amputation of the coronal pulp tissue.
• No pulp tissue remains when the pulp chamber is accessed.
• Pus discharges from the canal.
• Radiographically, only primary molars with at least two-thirds of the root length.
• Presence of inter-radicular or periapical radiolucency.

You may not qualify if:

• \. A tooth with internal root resorption will not be included. 2. Excessive tooth mobility beyond healing. 3. Carious perforation in the pulpal flour. 4. A tooth with a pathological lesion extending to the successor's tooth germ. 5. Non-restorable primary molars.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Toothache

Interventions

allyl sulfide; Calcium Hydroxide; iodoform; Ointments; Metapex

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Mennat Allah A. A. Elkareem

CONTACT

+20 1026022605; mennatallah.ashraf@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD degree student, Faculty of Dentistry, Cairo University.

Study Record Dates

• First Submitted: December 25, 2024
• First Posted: January 1, 2025
• Study Start: August 8, 2025
• Primary Completion (Estimated): October 8, 2026
• Study Completion (Estimated): November 8, 2026
• Last Updated: March 20, 2025

Record last verified: 2025-03