Infected Root Canals of Primary MolarsNCT03795636
Allium Sativum Extract as an Irrigant
A study testing Garlic extract and NaOCl (COLTENE®) in people with Infected Root Canals of Primary Molars, run by Minia University.
Trial summary
Garlic extract as herbal compound has potent antibacterial properties and can be used safely as an irrigant for pulpectomy procedure of primary molars root canals with high clinical and radiographic outcomes Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Infected Root Canals of Primary Molars
- What is being tested?
- Garlic extract and NaOCl (COLTENE®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2016to 15 Aug 2018
- 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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Class I or II according to American Society of Anesthesiologists (ASA)
- Irreversible pulpititis recognised through; (1) profuse bleeding from root canal orifices after complete debridement of coronal pulp tissue and cannot be dominated by moist cotton pellet. (2) History of lingered thermal pain spontaneous nocturnal pain
- Necrotic pulp tissues which may be asymptomatic or manifested with dull ache pain
- Pathological tooth mobility
- Percussion sensitivity
- Swelling close to involved tooth accompanied with or without fistula Radiographic characteristics of the root and supporting structures
Show all 9Show fewer
- 1. Normal radiographic findings
- 2. Interruption of lamina dura
- 3. Furcation radiolucency
Who cannot join
- Specifications of exclusion
- Uncooperativeness of child and/or parents or caregivers behavior
- Unrestorable tooth
- Presence of internal root resorption
- Presence of calcific metamorphosis inside root canals
- Presence of root resorption exceeding one third of its length
About this study
Official title: Allium Sativum Extract as an Irrigant in Pulpectomy of Primary Molars: 12 Month In-vivo Study
Garlic extract as herbal compound has potent antibacterial properties and can be used safely as an irrigant for pulpectomy procedure of primary molars root canals with high clinical and radiographic outcomes
Read the detailed description
Aim: This study indented to assess the clinical and radiographic assessment of garlic extract as an intracanal irrigant for pulpectomy of primary molars.
Methodology: 91 child with 100 teeth submitted into this study were equally categorized into the test group (group 1) which irrigated with garlic extract and control group (group 2) that received sodium hypochlorite (NaOCl). Then, each group has been subjected to further specification according to the tooth preoperative clinical and radiographic features into has been into 2 subgroups. Clinical and radiographic success rates were checked at 3, 6 and 12 months. Fisher's exact test for binary variable was used for data analysis with p-value ≤ 0.05.
- Conditions
- Infected Root Canals of Primary Molars
- Being tested
- Garlic extract, NaOCl (COLTENE®)
- Keywords
- Primary molars, Garlic extract, Sodium hypochlorite, Pulpectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garlic extractOther
A 100 gram of garlic cloves has been cleaned, peeled and dried. Ethanol of 70% concentration was added for 60 seconds. The cloves were placed in a laminar airflow chamber for evaporation of residual ethanol. Using a sterile mortar and pestle, cloves were homogenized aseptically and filtered through a double layer paper. The fully concentrated extracted was diluted to the concentration of 25% with distilled water
NaOCl (COLTENE®)Other
Sodium hypochlorite
| Study group | Role | What they receive |
|---|---|---|
| Garlic extracts root canal irrigation group | Experimental | Experimental group treated with garlic extract
A 100 gram of garlic cloves has been cleaned, peeled and dried. Ethanol of 70% concentration was added for 60 seconds. The cloves were placed in a laminar airflow chamber for evaporation of residual ethanol. Using a sterile mortar and pestle, cloves were homogenized aseptically and filtered through a double layer paper. The fully concentrated extracted was diluted to the concentration of 25% with distilled water Receives: Other: Garlic extract |
| Sodium hypochlorite root canal irrigation group | Active comparator | Control group which treated conventionally using .5 ml of 5.25% NaOCl (COLTENE®ENDO, Switzerland) Receives: Other: NaOCl (COLTENE®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral examination
Pain assessment using Visual Analog Score for pain
Measured: 12 months
radiographic success or failure
Radiographic assessment using periapical radiograph and score (0) applied for absence of radiolucency and score (1) for presence of radiolucency
Measured: 12 months
Secondary outcomes (1)
Types of failures
detecting the percent of different failure types accompanied with pulpectomy procedures after using garlic as an irrigant solution.
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 posted8 Jan 2019
- Study start30 Oct 2016
- Primary completion13 Aug 2018
- Study completion15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infected Root Canals of Primary MolarsStudies of the same condition, open and under way.
- More trials run by Minia 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
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Elheeny, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795636
- Sponsor's protocol ID
- 307
- Status last verified
- Oct 2019
- First submitted
- 2 Jan 2019
- Last updated
- 25 Oct 2019
- Results posted
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elheeny AAH. Allium sativum extract as an irrigant in pulpectomy of primary molars: A 12-month short-term evaluation. Clin Exp Dent Res. 2019 Jun 26;5(4):420-426. doi: 10.1002/cre2.197. eCollection 2019 Aug.
PubMed 31452953
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allium Sativum Extract as an Irrigant in Pulpectomy of Primary Molars: 12 Month In-vivo Study
- ClinicalTrials.gov ID
- NCT03795636
- Acronym / sponsor ID
- 307
- Conditions
- Infected Root Canals of Primary Molars
- Keywords
- Primary molars, Garlic extract, Sodium hypochlorite, Pulpectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 30 Oct 2016 (actual)
- Primary completion
- 13 Aug 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 8 Jan 2019 (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.
Garlic extract as herbal compound has potent antibacterial properties and can be used safely as an irrigant for pulpectomy procedure of primary molars root canals with high clinical and radiographic outcomes
Detailed description
Aim: This study indented to assess the clinical and radiographic assessment of garlic extract as an intracanal irrigant for pulpectomy of primary molars.
Methodology: 91 child with 100 teeth submitted into this study were equally categorized into the test group (group 1) which irrigated with garlic extract and control group (group 2) that received sodium hypochlorite (NaOCl). Then, each group has been subjected to further specification according to the tooth preoperative clinical and radiographic features into has been into 2 subgroups. Clinical and radiographic success rates were checked at 3, 6 and 12 months. Fisher's exact test for binary variable was used for data analysis with p-value ≤ 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Garlic extracts root canal irrigation group | Experimental | Other: Garlic extractExperimental group treated with garlic extract A 100 gram of garlic cloves has been cleaned, peeled and dried. Ethanol of 70% concentration was added for 60 seconds. The cloves were placed in a laminar airflow chamber for evaporation of residual ethanol. Using a sterile mortar and pestle, cloves were homogenized aseptically and filtered through a double layer paper. The fully concentrated extracted was diluted to the concentration of 25% with distilled water |
| Sodium hypochlorite root canal irrigation group | Active comparator | Other: NaOCl (COLTENE®)Control group which treated conventionally using .5 ml of 5.25% NaOCl (COLTENE®ENDO, Switzerland) |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Class I or II according to American Society of Anesthesiologists (ASA)
- Irreversible pulpititis recognised through; (1) profuse bleeding from root canal orifices after complete debridement of coronal pulp tissue and cannot be dominated by moist cotton pellet. (2) History of lingered thermal pain spontaneous nocturnal pain
- Necrotic pulp tissues which may be asymptomatic or manifested with dull ache pain
- Pathological tooth mobility
- Percussion sensitivity
Key exclusion criteria (6 listed)
- Specifications of exclusion
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 |
|---|---|---|
| Garlic extractA 100 gram of garlic cloves has been cleaned, peeled and dried. Ethanol of 70% concentration was added for 60 seconds. The cloves were placed in a laminar airflow chamber for evaporation of residual ethanol. Using a sterile mortar and pestle, cloves were homogenized aseptically and filtered through a double layer paper. The fully concentrated extracted was diluted to the concentration of 25% with distilled water | Other | Garlic extracts root canal irrigation group |
| NaOCl (COLTENE®)Sodium hypochlorite | Other | Sodium hypochlorite root canal irrigation group |
Primary outcome
oral examination
Time frame: 12 months
Pain assessment using Visual Analog Score for pain
radiographic success or failure
Time frame: 12 months
Radiographic assessment using periapical radiograph and score (0) applied for absence of radiolucency and score (1) for presence of radiolucency
1 secondary outcome
Types of failures
Time frame: 12 months
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 25 Oct 2019.
- Derived from this study: PubMed 31452953Elheeny AAH. Allium sativum extract as an irrigant in pulpectomy of primary molars: A 12-month short-term evaluation. Clin Exp Dent Res. 2019 Jun 26;5(4):420-426. doi: 10.1002/cre2.197. eCollection 2019 Aug.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing Garlic extract and NaOCl (COLTENE®) in people with Infected Root Canals of Primary Molars, run by Minia University.
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 9 inclusion and 6 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 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
oral examination (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 NCT03795636, which also lists 1 linked publication.
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 25 Oct 2019.