Pulp Disease, DentalNCT05633537
Clinical & Radiographic Evaluation of Zinc Oxide-Ozonated Oil as a New Primary Root Canal Filling
A study testing pulpectomy procedure and the clinical evaluation and radiographic evaluation in people with Pulp Disease, Dental and Obturation, run by Tanta University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp Disease, Dental, Obturation, Root Canal Infection
- What is being tested?
- pulpectomy procedure and the clinical evaluation and radiographic evaluation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Jul 2021to 29 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Zinc Oxide-Ozonated Oil as a New Root Canal Filling Material for Primary Molars
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.
Read the detailed description
Pulpectomy for primary teeth involves root canal preparation followed by obturation with a resorbable material. Zinc oxide eugenol (ZOE) is the most widely used obturating material. The main ZOE disadvantages are the difference in rate of resorption compared to the root, and limited antimicrobial activity. ZOE is formed when crude eugenol is mixed with zinc oxide. the set material easily hydrolyzes, resulting in free eugenol release which can be harmful to human soft tissues; this motivated the search for a new eugenol substitute to be combined with zinc oxide. Olive oil is a vegetable oil that comprises antioxidants, carotenoids, oleuropein, and oleocanthal, a phenolic component that significantly contributes to its antibacterial and anti-inflammatory properties. ozone in the form of ozonated olive oil, have the ability to produce nascent oxygen deep into the treated area without triggering irritation so, improved rheological characteristics, increased intracellular ATP, stimulated cellular metabolism, and expression of cytokines related to healing, particularly Transforming Growth Factor.
- Conditions
- Pulp Disease, Dental, Obturation, Root Canal Infection
- Being tested
- pulpectomy procedure and the clinical evaluation, radiographic evaluation
- Keywords
- pulpectomy, Ozonated Olive Oil, zinc oxide eugenol, primary molars
- Medical subject headings
- Dental Pulp Diseases, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulpectomy procedure and the clinical evaluationProcedure or surgery
Also called clinical evaluation of root canal treatment of primary molars
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).
radiographic evaluationRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Procedure: pulpectomy procedure and the clinical evaluation; Radiation: radiographic evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start4 Jul 2021
- Primary completion1 Mar 2023
- Study completion29 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pulp Disease, DentalStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Shaban Mohamed El-desouky, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633537
- Sponsor's protocol ID
- #R- PED-1-21-2
- Status last verified
- Dec 2023
- First submitted
- 21 Nov 2022
- Last updated
- 7 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21991471Chandra 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.
PubMed 24197970Sarrami 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.
PubMed 12353045Ulusoy 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.
PubMed 31882036Saini 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.
PubMed 22346227
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Zinc Oxide-Ozonated Oil as a New Root Canal Filling Material for Primary Molars
- ClinicalTrials.gov ID
- NCT05633537
- Acronym / sponsor ID
- #R- PED-1-21-2
- Conditions
- Pulp Disease, Dental, Obturation, Root Canal Infection
- Keywords
- pulpectomy, Ozonated Olive Oil, zinc oxide eugenol, primary molars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 4 Jul 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 29 May 2023 (actual)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pulpectomy for primary teeth involves root canal preparation followed by obturation with a resorbable material. Zinc oxide eugenol (ZOE) is the most widely used obturating material. The main ZOE disadvantages are the difference in rate of resorption compared to the root, and limited antimicrobial activity. ZOE is formed when crude eugenol is mixed with zinc oxide. the set material easily hydrolyzes, resulting in free eugenol release which can be harmful to human soft tissues; this motivated the search for a new eugenol substitute to be combined with zinc oxide. Olive oil is a vegetable oil that comprises antioxidants, carotenoids, oleuropein, and oleocanthal, a phenolic component that significantly contributes to its antibacterial and anti-inflammatory properties. ozone in the form of ozonated olive oil, have the ability to produce nascent oxygen deep into the treated area without triggering irritation so, improved rheological characteristics, increased intracellular ATP, stimulated cellular metabolism, and expression of cytokines related to healing, particularly Transforming Growth Factor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1: zinc oxide-ozonated olive oil | Experimental | Procedure: pulpectomy procedure and the clinical evaluation, Radiation: radiographic evaluationGroup 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 |
| group 2: zinc oxide- olive oil | Experimental | Procedure: pulpectomy procedure and the clinical evaluation, Radiation: radiographic evaluationGroup 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 |
| group 3:zinc oxide- eugenol | Active comparator | Procedure: pulpectomy procedure and the clinical evaluation, Radiation: radiographic evaluationGroup 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 |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy \& cooperative child
- history of spontaneous pain
- Percussion sensitivity
- presence of inter-radicular or periapical radiolucency
- No internal root resorption
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulpectomy procedure and the clinical evaluationAlso: clinical evaluation of root canal treatment of primary molarsin 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). | Procedure or surgery | group 1: zinc oxide-ozonated olive oil, group 2: zinc oxide- olive oil, group 3:zinc oxide- eugenol |
| radiographic evaluationRadiographic 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. | Radiation | group 1: zinc oxide-ozonated olive oil, group 2: zinc oxide- olive oil, group 3:zinc oxide- eugenol |
Primary outcome
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)
Time frame: 12 months
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 )
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)
Time frame: 12 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Background: PubMed 21991471Barja-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.
- Background: PubMed 24197970Chandra 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.
- Background: PubMed 12353045Sarrami 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.
- Background: PubMed 31882036Ulusoy 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.
- Background: PubMed 22346227Saini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulpectomy procedure and the clinical evaluation and radiographic evaluation in people with Pulp Disease, Dental and Obturation, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05633537, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.