Clinical & Radiographic Evaluation of Zinc Oxide-Ozonated Oil as a New Primary Root Canal Filling

NCT05633537 | Completed

• 1 other identifier: #R- PED-1-21-2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Preserving primary teeth is essential for many aspects such as the child's growth and development, esthetic, functional, psychological, and dental arch integrity aspects. a randomized blinded controlled clinical trial aimed to evaluate the clinical and radiographic success of Zinc Oxide-Ozonated Olive Oil as root canal filling materials for primary molars compared to Zinc Oxide-Olive Oil \& Zinc Oxide-eugenol. 90 primary molars of 30 children aged between 4-8 years with pulpally involved primary molars, are equally divided into 3 groups which treated with Zinc Oxide-Ozonated Olive Oil , zinc oxide -olive oil and zinc oxide eugenol as obturation materials following pulpectomy procedure. The subjects were followed up clinically and radiographically at 3, 6 and 12 months.

Conditions

Pulp Disease, Dental; Obturation; Root Canal Infection

Keywords

pulpectomy; Ozonated Olive Oil; zinc oxide eugenol; primary molars

Outcome Measures

Primary Outcomes (2)

• clinical success of primary molar pulpectomy after using new root canal filling materials (Zinc Oxide-Ozonated olive Oil , Zinc Oxide- olive Oil) compared to the widely used material (zinc oxide material)

  by assessing the presence or absence of spontaneous pain, presence or absence of tenderness with percussion, presence or absence of abnormal mobility and presence or absence of swelling and/or fistula during the follow-up intervals ( three, six and twelve months )

  12 months

• radiographic success of primary molar pulpectomy after using new root canal filling materials (Zinc Oxide-Ozonated olive Oil , Zinc Oxide- olive Oil) compared to the widely used material (zinc oxide material)

  by assessing the presence or absence of extensive pathologic root resorption, reduction or no change in pre-operative pathologic inter-radicular radiolucency and presence or absence of new postoperative pathologic radiolucency. the assessment is done using periapical radiographs at three, six and twelve months after pulpectomy procedure.

  12 months

Study Arms (3)

group 1: zinc oxide-ozonated olive oil

EXPERIMENTAL

Group I: 30 primary molars were filled with fresh mix of zinc oxide powder with ozonated olive oil A single-visit pulpectomy procedure was performed . Standardized preoperative periapical radiograph was obtained to assess tooth condition \& proper selection. Teeth were anesthetized \& Rubber dam isolation was done, then all caries was removed \& access opening was gained. Working length was determined by apex locator. All canals were prepared using Kidzo file system in a lateral brushing motion with an Endo-Mate DT endodontic motor at 350 RPM and 2.5 N/cm torque. EDTA gel 17% will be used before instrumentation \& irrigation was done with normal saline. Dryness with paper points size 30 . placement of the root canal filling material (zinc oxide-ozonated olive oil) was applied . Intermediate restorative material was placed, then tooth was restored with stainless-steel crown

Procedure: pulpectomy procedure and the clinical evaluation; Radiation: radiographic evaluation

group 2: zinc oxide- olive oil

EXPERIMENTAL

Group 2: 30 primary molars were filled with fresh mix of zinc oxide powder with olive oil A single-visit pulpectomy procedure was performed . Standardized preoperative periapical radiograph was obtained to assess tooth condition \& proper selection. Teeth were anesthetized \& Rubber dam isolation was done, then all caries was removed \& access opening was gained. Working length was determined by apex locator. All canals were prepared using Kidzo file system in a lateral brushing motion with an Endo-Mate DT endodontic motor at 350 RPM and 2.5 N/cm torque. EDTA gel 17% will be used before instrumentation \& irrigation was done with normal saline. Dryness with paper points size 30 . placement of the root canal filling material (zinc oxide- olive oil) was applied . Intermediate restorative material was placed, then tooth was restored with stainless-steel crown

Procedure: pulpectomy procedure and the clinical evaluation; Radiation: radiographic evaluation

group 3:zinc oxide- eugenol

ACTIVE COMPARATOR

Group 3: 30 primary molars were filled with zinc oxide- eugenol A single-visit pulpectomy procedure was performed . Standardized preoperative periapical radiograph was obtained to assess tooth condition \& proper selection. Teeth were anesthetized \& Rubber dam isolation was done, then all caries was removed \& access opening was gained. Working length was determined by apex locator. All canals were prepared using Kidzo file system in a lateral brushing motion with an Endo-Mate DT endodontic motor at 350 RPM and 2.5 N/cm torque. EDTA gel 17% will be used before instrumentation \& irrigation was done with normal saline. Dryness with paper points size 30 . placement of the root canal filling material (zinc oxide- eugenol) was applied . Intermediate restorative material was placed, then tooth was restored with stainless-steel crown

Procedure: pulpectomy procedure and the clinical evaluation; Radiation: radiographic evaluation

Interventions

pulpectomy procedure and the clinical evaluation PROCEDURE

in this study, pulpectomy procedure was performed in a single visit and the root canals were filled with different obturating materials. The clinical follow up evaluation was carried out after three, six and twelve months after pulpectomy procedures. The teeth were clinically evaluated each follow up visit for the following clinical features: absence of spontaneous pain, no tenderness with percussion, no abnormal mobility and absence of swelling \& sinus or fistula. If the tooth exhibited any one of above clinical features, the pulpectomy was considered to be a failure (F); otherwise, it was regarded as clinical success (S).

Also known as: clinical evaluation of root canal treatment of primary molars

group 1: zinc oxide-ozonated olive oil; group 2: zinc oxide- olive oil; group 3:zinc oxide- eugenol

radiographic evaluation RADIATION

Radiographic evaluation was performed immediately after teeth restoration (base line radiograph), then after three, six and twelve months. The parallel periapical technique was performed using the rinn (XCP) periapical film holder and a long cone which was mounted to the x-ray tube. The criteria for radiographic success were no evidence of extensive pathologic root resorption, reduction or no change in pre-operative pathologic inter-radicular radiolucency and no evidence of new postoperative pathologic radiolucency.

group 1: zinc oxide-ozonated olive oil; group 2: zinc oxide- olive oil; group 3:zinc oxide- eugenol

Eligibility Criteria

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

You may qualify if:

• Healthy \& cooperative child
• history of spontaneous pain
• Percussion sensitivity
• presence of inter-radicular or periapical radiolucency
• No internal root resorption
• External root resorption limited to apical third and with at least two-thirds root intact.

You may not qualify if:

• Uncooperativeness of child and/or parents
• Unrestorable tooth
• Presence of calcific metamorphosis inside root canals
• Tooth with evidence of extensive internal/external pathological root resorption.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, 6624033, Egypt

Location

Related Publications (5)

• Barja-Fidalgo F, Moutinho-Ribeiro M, Oliveira MA, de Oliveira BH. A systematic review of root canal filling materials for deciduous teeth: is there an alternative for zinc oxide-eugenol? ISRN Dent. 2011;2011:367318. doi: 10.5402/2011/367318. Epub 2010 Oct 17.

  PMID: 21991471 BACKGROUND

• Chandra SP, Chandrasekhar R, Uloopi KS, Vinay C, Kumar NM. Success of root fillings with zinc oxide-ozonated oil in primary molars: preliminary results. Eur Arch Paediatr Dent. 2014 Jun;15(3):191-5. doi: 10.1007/s40368-013-0094-8. Epub 2013 Nov 6.

  PMID: 24197970 BACKGROUND

• Sarrami N, Pemberton MN, Thornhill MH, Theaker ED. Adverse reactions associated with the use of eugenol in dentistry. Br Dent J. 2002 Sep 14;193(5):257-9. doi: 10.1038/sj.bdj.4801539.

  PMID: 12353045 BACKGROUND

• Ulusoy OI, Ekici MAG, Alacam T, Bari E, Ulusoy C. Virgin Olive Oil, Soybean Oil, and Hank's Balanced Salt Solution Used as Storage Media on Periodontal Ligament Cell Viability. Pediatr Dent. 2019 Nov 15;41(6):485-488.

  PMID: 31882036 BACKGROUND

• Saini R. Ozone therapy in dentistry: A strategic review. J Nat Sci Biol Med. 2011 Jul;2(2):151-3. doi: 10.4103/0976-9668.92318.

  PMID: 22346227 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Diseases; Bites and Stings

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pediatric dentistry

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 1, 2022
• Study Start: July 4, 2021
• Primary Completion: March 1, 2023
• Study Completion: May 29, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-12

Locations

EG (1)