Clinical and Radiographic Evaluation of Zinc Oxide Modified 3Mixtatin Versus Zical in Root Canal Treatment of Necrotic Primary Molars.

NCT06752889 | Recruiting DMC

• 1 other identifier: PED21-9
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Primary molars with necrotic pulp or abscess are common unfortunate event faced in pediatric dentistry .The traditional treatment is either pulpectomy or extraction. ٍuccess of pulpectomy treatment is about 85% in abscessed primary teeth. The aim of pulpectomy is to preserve teeth in a symptom free state until they are replaced by their successor naturally during the transition from primary to permanent dentition, thus avoiding extraction. The adequate restoration of the involved teeth may preserve the arch length reestablish the masticatory function and esthetics and prevent harmful tongue habits and speech alterations due to anterior teeth decay.

Conditions

Necrotic Pulp; Primary Teeth

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  spontaneous pain, as reported by the caregivers through visual analogue score (VAS)from 1 to 10 where 1 means : minimal pain , 10 means:: severe pain

  first week after treatment, 3 months, 6 months, 12 months

Secondary Outcomes (2)

• Root resorption

  preoperative, 3rd month, 6 month, 12 month

• Bone resorption

  preoperative, 3 , 6 , 12 month

Study Arms (2)

Group( 1): Control Group (pulpectomy using zic oxide eugenol based sealer Zical):

ACTIVE COMPARATOR

Local anesthesia administration and rubber dam isolation will be carried out Access cavity will be prepared, necrotic pulp tissue will be removed using a sterile sharp spoon excavator. Cleaning and shaping of the root canals will be carried out using H files and continuous irrigation. Canal irrigation with 2.5% sodium hypochlorite will be carried out throughout the procedure. Sterile paper points will be used to dry the root canals. Zinc oxide eugenol based sealer (Zical) will be mixed into a thick paste and packed into the pulp chamber to fill the canal. (Chen\& Zhong., 2017; Pramila., 2015) The access opening will be sealed with a glass ionomer cement , and the tooth will be restored with a stainless steel crown.

Other: Group( 1): Control Group (pulpectomy using zic oxide eugenol based sealer Zical):

Group ( 2) Experimental group modified 3-MIX-TATIN):

EXPERIMENTAL

dified 3Mix-tatin will be prepared by mixing three commercially available antibiotics with simvastatin. After removing the coating materials, 3 types of antibiotics are pulverized by porcelain mortars and pestles to achieve fine powders. A total of 100 mg ciprofloxacin, 100 mg metronidazole, and 100 mg cefixime will be mixed in a ratio of 1: 1: 1. Two milligrams of simvastatin will be added to the drugs blend to form 3-Mix-tatin. Preparation of 3Mix-tatin will be trained and supervised by an expert pharmacist. 3Mixtatin will be stored in a tightly capped porcelain container, adding of silica gel in a bag inside the container to maintain low humidity. This powder will be mixed with zinc oxide eugenol based sealer called Zical which will act as a carrier or vehicle to form a creamy paste of 3Mixtatin at the time of application (Aminabadi et al., 2015; carvalho., 2016).

Other: Group ( 2) Experimental group modified 3-MIX-TATIN):

Interventions

Group( 1): Control Group (pulpectomy using zic oxide eugenol based sealer Zical): OTHER

Zinc oxide eugenol based sealer (Zical) will be mixed into a thick paste and packed into the pulp chamber to fill the canal.

Group( 1): Control Group (pulpectomy using zic oxide eugenol based sealer Zical):

Group ( 2) Experimental group modified 3-MIX-TATIN): OTHER

Modified 3Mix-tatin will be prepared by mixing three commercially available antibiotics with simvastatin. This powder will be mixed with zinc oxide eugenol based sealer called Zical which will act as a carrier or vehicle to form a creamy paste of 3Mixtatin at the time of application

Group ( 2) Experimental group modified 3-MIX-TATIN):

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children age range from 5-7 years.
• Children free from any systemic diseases or genetic disorders.
• Primary molar with necrotic pulp, with pain, gingival abscess, sinus openings.
• Clinical mobility not exceeding grade two.
• Radiographic evidence of non-perforating internal resorption, external resorption not exceeding 1\\3 of the root
• Furcation or periapical radiolucency.

You may not qualify if:

• Non-restorable molars or beyond repair, for example: decay reaches to bifurcation, a hard gingival margin cannot be established or infection cannot be eradicated by other mean (Balaji, 2007).
• Patient with known allergy to any type of antibiotics or anti-hyperlipidemia drugs.
• Patient with facial cellulitis or lymphadenopathy
• Lack of patient/parent compliance and cooperation.
• Refusal of participation or failure to obtain an informed consent.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Cairo Governorate, 002, Egypt

RECRUITING

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• amira badran, Phd

  associate professor

  STUDY DIRECTOR

Central Study Contacts

Mahmoud Sa'adoon, master

CONTACT

201115082428; drmahmoudsa3doon@gmail.com

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: SPONSOR

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: December 31, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)