Gingival BleedingmouthwashNCT03166163
Evaluation of Bleeding on Brushing Using Neem Extract Mouthwash Versus Chlorhexidine Mouthwash
A study testing Azadirachta indica and Chlorhexidine mouthwash in people with Gingival Bleeding, run by Cairo University at 1 site in Egypt.
Trial summary
i will compare the effect of neem extract mouthwash versus the chlorhexidine mouthwash on bleeding on brushing among a group of Egyptian children. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Bleeding
- What is being tested?
- Azadirachta indica and Chlorhexidine mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2017to 11 Jun 2017
- 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 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1. Children aged 8-10 years old with gingivitis
- 2. cooperative children
- 3.both genders
- 4.medically free
- 5. sulcus bleeding index score is 2
Who cannot join
- 1. Children undergoing orthodontic treatment
- 2.Children undergoing any other oral hygiene aid other than routine teeth brushing
- 3.Children with known history of allergy to any mouthwash or drug
- 4.Parents unable to give informed consent
- 5.Children taking antibiotic or antiseptic in previous two months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Bleeding on Brushing Among a Group of Egyptian Children After Using Azadirachta Indica (Neem Extract)Mouthwash Versus Chlorhexidine Mouthwash: A Randomized Controlled Trial
i will compare the effect of neem extract mouthwash versus the chlorhexidine mouthwash on bleeding on brushing among a group of Egyptian children.
Read the detailed description
- First , we will select the patients according to the inclusion criteria.
- We will take sulcus bleeding index which is defined as an index of gingival inflammation in which bleeding is measured from four gingival units using a periodontal probe. The scoring is ranging around eight anterior teeth from 0 to 5.In this study, we will take only score 2 which is bleeding on probing, change in colour and no edema in order to reduce variability.
- 2%neem extract will be used to prepare mouthwash while, chlorhexidine will be used as positive control.
- Chlorhexidine will be coded with the letter "A" and the mouthwash of 2%neem extract with the letter "B".
- The participants included will be allocated into 2 groups by drawing of sealed and opaque envelopes containing the codes "A" and "B"
- The intra and extraoral examinations will be made using masks, gloves, cap, goggles, gauze, medical tray, dental mirror and WHO probe. All materials will be packaged in sterilization wraps and autoclaved, following the required biosafety standards.
- The rinses will be performed twice daily, which will be supervised by the parents legal guardians previously instructed. Kits containing toothpaste an brush will be provided, so that the patients will use the same toothpaste, avoiding any interference with the results.
- After 3 weeks, we will ask the patient if there is any gingival bleeding in addition we will measure the sulcus bleeding index.
- Conditions
- Gingival Bleeding
- Being tested
- Azadirachta indica, Chlorhexidine mouthwash
- Keywords
- bleeding on brushing
- Medical subject headings
- Gingival Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azadirachta indicaDrug
Also called neem extract
Its a herbal mouthwash that will be given to group of Egyptian Children twice daily for 3 weeks
Chlorhexidine mouthwashDrug
Also called chlohexidine
its an antimocrobial, antiplaque mouthwash that will be given to a group of Egyptian children twice daily (10 ml each) for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Azadirachta indica (Neem extract) | Experimental | its herbal mouthwash that will be given to a group a Egyptian children twice a day(10 ml each) for 3 weeks Receives: Drug: Azadirachta indica |
| chlorhexidine mouthwash | Active comparator | its an antimoicrobial, antiplaque mouthwash that will be given to a group of Egyptian children twice daily(10 ml each) for 3 weeks Receives: Drug: Chlorhexidine mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on brushing
measuring device(asking the patient) measuring unit (binary)
Measured: 3 weeks
Secondary outcomes (1)
sulcus bleeding index
measuring device (measuring the sulcus bleeding index) measuring unit (the score of the sulcus bleeding index)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start20 May 2017
- Primary completion11 Jun 2017 (estimated)
- Study completion11 Jun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gingival BleedingStudies of the same condition, open and under way.
- More trials run by Cairo 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, Investigator
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Sherif Ali Mostafa, Cairo University
- Investigators
- Sherif B Eltaweel, Ass. prof, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166163
- Sponsor's protocol ID
- 2621985
- Other IDs
- 2621985
- Acronym
- mouthwash
- Status last verified
- May 2017
- First submitted
- 23 May 2017
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: it will be available when it is finished
Publications
Balappanavar AY, Sardana V, Singh M. Comparison of the effectiveness of 0.5% tea, 2% neem and 0.2% chlorhexidine mouthwashes on oral health: a randomized control trial. Indian J Dent Res. 2013 Jan-Feb;24(1):26-34. doi: 10.4103/0970-9290.114933.
PubMed 23852229Dhingra K, Vandana KL. Effectiveness of Azadirachta indica (neem) mouthrinse in plaque and gingivitis control: a systematic review. Int J Dent Hyg. 2017 Feb;15(1):4-15. doi: 10.1111/idh.12191. Epub 2016 Feb 15.
PubMed 26876277
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bleeding on Brushing Among a Group of Egyptian Children After Using Azadirachta Indica (Neem Extract)Mouthwash Versus Chlorhexidine Mouthwash: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03166163
- Acronym / sponsor ID
- mouthwash / 2621985
- Conditions
- Gingival Bleeding
- Keywords
- bleeding on brushing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 May 2017 (actual)
- Primary completion
- 11 Jun 2017 (estimated)
- Study completion
- 11 Jun 2017 (estimated)
- First posted
- 25 May 2017 (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.
i will compare the effect of neem extract mouthwash versus the chlorhexidine mouthwash on bleeding on brushing among a group of Egyptian children.
Detailed description
- First , we will select the patients according to the inclusion criteria.
- We will take sulcus bleeding index which is defined as an index of gingival inflammation in which bleeding is measured from four gingival units using a periodontal probe. The scoring is ranging around eight anterior teeth from 0 to 5.In this study, we will take only score 2 which is bleeding on probing, change in colour and no edema in order to reduce variability.
- 2%neem extract will be used to prepare mouthwash while, chlorhexidine will be used as positive control.
- Chlorhexidine will be coded with the letter "A" and the mouthwash of 2%neem extract with the letter "B".
- The participants included will be allocated into 2 groups by drawing of sealed and opaque envelopes containing the codes "A" and "B"
- The intra and extraoral examinations will be made using masks, gloves, cap, goggles, gauze, medical tray, dental mirror and WHO probe. All materials will be packaged in sterilization wraps and autoclaved, following the required biosafety standards.
- The rinses will be performed twice daily, which will be supervised by the parents legal guardians previously instructed. Kits containing toothpaste an brush will be provided, so that the patients will use the same toothpaste, avoiding any interference with the results.
- After 3 weeks, we will ask the patient if there is any gingival bleeding in addition we will measure the sulcus bleeding index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azadirachta indica (Neem extract) | Experimental | Drug: Azadirachta indicaits herbal mouthwash that will be given to a group a Egyptian children twice a day(10 ml each) for 3 weeks |
| chlorhexidine mouthwash | Active comparator | Drug: Chlorhexidine mouthwashits an antimoicrobial, antiplaque mouthwash that will be given to a group of Egyptian children twice daily(10 ml each) for 3 weeks |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 1. Children aged 8-10 years old with gingivitis
- 2. cooperative children
- 3.both genders
- 4.medically free
- 5. sulcus bleeding index score is 2
Key exclusion criteria (5 listed)
- 1. Children undergoing orthodontic treatment
- 2.Children undergoing any other oral hygiene aid other than routine teeth brushing
- 3.Children with known history of allergy to any mouthwash or drug
- 4.Parents unable to give informed consent
- 5.Children taking antibiotic or antiseptic in previous two months
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 |
|---|---|---|
| Azadirachta indicaAlso: neem extractIts a herbal mouthwash that will be given to group of Egyptian Children twice daily for 3 weeks | Drug | Azadirachta indica (Neem extract) |
| Chlorhexidine mouthwashAlso: chlohexidineits an antimocrobial, antiplaque mouthwash that will be given to a group of Egyptian children twice daily (10 ml each) for 3 weeks | Drug | chlorhexidine mouthwash |
Primary outcome
Bleeding on brushing
Time frame: 3 weeks
measuring device(asking the patient) measuring unit (binary)
1 secondary outcome
sulcus bleeding index
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
- Background: PubMed 23852229Balappanavar AY, Sardana V, Singh M. Comparison of the effectiveness of 0.5% tea, 2% neem and 0.2% chlorhexidine mouthwashes on oral health: a randomized control trial. Indian J Dent Res. 2013 Jan-Feb;24(1):26-34. doi: 10.4103/0970-9290.114933.
- Background: PubMed 26876277Dhingra K, Vandana KL. Effectiveness of Azadirachta indica (neem) mouthrinse in plaque and gingivitis control: a systematic review. Int J Dent Hyg. 2017 Feb;15(1):4-15. doi: 10.1111/idh.12191. Epub 2016 Feb 15.
- Comparison of the effectiveness of 0.5% tea, 2% neem and 0.2% chlorhexidine mouthwashes on oral health: a randomized control trial.Link provided by the sponsor.
- Effectiveness of Azadirachta indica (neem) mouthrinse in plaque and gingivitis control: a systematic review.Link provided by the sponsor.
- Individual participant dataSharing planned: No. it will be available when it is finished
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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.
Sherif B Eltaweel, Ass. prof study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Azadirachta indica and Chlorhexidine mouthwash in people with Gingival Bleeding, run by Cairo 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 May 2017. 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?
Results are not available in the source record.
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?
Bleeding on brushing (time frame: 3 weeks). 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 NCT03166163, which also lists 2 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 25 May 2017.