Dental CariesPhase 1NCT03724578
Grape Seeds Versus Standard Measures for Prevention of Caries Incidence
A Phase 1 study testing Grape Seed Extract mouth wash, standard preventive measures and antimicrobial and fluoride mouth wash in people with Dental Caries, run by Cairo University.
Trial summary
The objective is to conduct an randomized controlled clinical trial to evaluate the effectiveness of grape seeds extract mouth wash in comparison with standard caries preventive measures for the prevention of new carious lesions in high caries risk patients. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Grape Seed Extract mouth wash, standard preventive measures and antimicrobial and fluoride mouth wash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 1 Mar 2020
- Phase
- Phase 1
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with High caries risk
- 18-25 years
- Males or females
- Medically free patients
- Patients approving to participate in the study
Who cannot join
- • Patients were on antibiotic therapy or corticosteroid therapy for 30 days before the examination
- Patients had history of professional cleaning in the last 15 days
- Patients with exposed pulp
- Evidence of parafunctional habits
- Patients with developmental dental anomalies
- Patients undergoing or will start orthodontic treatment
- Patients with removable prosthesis
- Periapical Abscess or Fistula
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Grape Seeds Versus Standard Measures for Prevention of Caries Incidence in Young Egyptian Adults: A Randomized Controlled Trial
The objective is to conduct an randomized controlled clinical trial to evaluate the effectiveness of grape seeds extract mouth wash in comparison with standard caries preventive measures for the prevention of new carious lesions in high caries risk patients.
This study will be designed to test the alternative hypothesis that using grape seed extract mouth wash in addition to standard preventive measures will show significant difference over using standard preventive measures alone in preventing incidence of new carious lesions in high caries risk patients
Read the detailed description
Research Question:
In high caries risk patients, will the incorporation of grape seeds extract after using standard oral hygiene measures be beneficial in reducing caries risk and preventing the incidence of new carious lesions?
Intervention:
The study will be announced at the Faculty of Oral and Dental Medicine, Future University campus to encourage interested students to participate in the study.
Interested participants will be screened at Conservative Department clinic for eligibility. Eligible participants will be assessed using caries risk assessment tool (American Dental Association caries risk assessment form).
Eligible participants will be randomly divided into three groups 1st group will follow only standard preventive measures (tooth brushing twice a day with fluoride tooth paste and inter-dental flossing once daily), 2nd group will use grape seeds extract mouth wash beside standard preventive measure, and 3rd group will use antimicrobial mouthwash with fluoride beside standard preventive measure General operative procedures Before starting the study the eligible participants will undergo scaling and prophylaxis polishing, then any carious cavity, or defective restoration will be treated and filled with resin composite restoration.
New set of manual brushes and dental floss will be given to the participants, after they are properly trained for the correct brushing and flossing technique. The participants will be asked to brush their teeth twice a day with fluoride tooth paste and to clean their teeth inter-dentally with dental floss once a day every day till the end of the study. All the participants will undergo scaling and prophylaxis polishing at every recall visit Preparation of the grape seeds extract mouthwash
- Procedure of preparing Grape Seed Extract:
Grape seeds will be collected from grapes which are available in the market. These seeds will be dried under sunlight for 2 days, and then these seeds will be grounded with cold pressure technique. Ground grape seeds (100 gm) will be extracted with ethanol/water ratio of 70:30, vol/vol, by maceration method under stirring at 45 degree centigrade for 2 hours, then The extract will be filtered(19).
For the intervention 1 group Beside the standard preventive measures that the participants will be trained to follow, each patient will be given a bottle of grape seeds extract mouthwash.
The participants will be instructed to rinse 15 milliliter of the mouthwash twice a day after breakfast and before bedtime and to retain it in their mouth for one minute before expectorating it, and not to consume any food or drink for 30 minutes after the use of mouthwash(12).
For intervention 2 group The participants will be instructed to rinse 15 milliliter of the mouth twice a day after breakfast and before bedtime and to retain it in their mouth for one minute before expectorating it, and not to consume any food or drink for 30 minutes after the use of mouthwash. Participants will repeat this protocol for five days every month until the end of the study.
For the control group Participants in this group will follow only the standard preventive measures which is brushing twice a day after breakfast and before bed time and daily flossing inter-dentally before bed time.
In all study groups if any patient during the period of the study develops any carious cavity, the affected tooth will be treated immediately and restored with resin composite restoration.
Outcomes:
Visual inspection to detect presence or absence of new caries lesions will be done according to World Health Organization guidelines. Caries detection will be carried out after careful drying of the tooth surface using three-way syringe to facilitate detection of initial enamel lesions (white spot lesions). Also pits and fissure carious lesions will be detected using visual and tactile method. (26).
Sample size:
The aim of this study is to assess Incidence of new caries in Grape seeds versus standard measures for prevention of caries. Based on a previous paper by Zhang 2006(27) the difference in caries development (reduction by antimicrobial mouth wash) between at least 2 groups is 40%. Using power 80% and 5% significance level the investigators will need to study 22 in each group. This number is to be increased to a sample size of 26 to compensate for losses during follow up. Sample size calculation was achieved using PS: Power and Sample Size Calculation software Version 3.1.2 (Vanderbilt University, Nashville, Tennessee, USA
Recruitment:
Patients will be recruited by (S.K and O.N) from the students of Faculty of Oral and Dental medicine, Future University as the research is targeting young Egyptian adults, only the eligible participants will be chosen until reaching the target sample size.
-Baseline data collection: For every patient medical and dental history and caries risk assessment profile will be obtained. Examination chart will be filled by (O.N)
Outcome data collection:
Visual caries inspection and community periodontal index probe(28) will be used by the assessor (S.K and E.A) after 3 months, 6 months, 9 months and 1 year to evaluate the presence or absence of new caries lesions.
Patient retention:
The patient's phone number will be recorded in their charts and before every visit the patient will receive a reminder call by (O.N). If the patient did not answer, another appointment will be scheduled within a week.
No harms are expected as the intervention product is natural product and Considered as (generally recognized as safe) by The FDA (Food and Drug Administration Informed consent The trial will be explained to the patients by the principle investigator. The researcher will discuss the interventions and possible harms with patients and obtain written consent (in Arabic) from the patients willing to participate in the trial. An appendix of the consent form is attached to the protocol
Post-trial care All patients will complete their treatment by the same operator at the clinic of the Conservative Department. The participants will be followed up even after the trial ends (6 months follow up period) to treat patient's complaints and prevent any possible complications
- Conditions
- Dental Caries
- Being tested
- Grape Seed Extract mouth wash, standard preventive measures, antimicrobial and fluoride mouth wash
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape Seed Extract mouth washDrug
participants will use grape seeds extract mouth wash in addition to standard preventive measures
standard preventive measuresDrug
twice daily brushing with fluoride tooth pate and daily flossing
antimicrobial and fluoride mouth washDrug
using chlorhexidine and fluoride containing mouth wash
| Study group | Role | What they receive |
|---|---|---|
| standard preventive measures | Sham comparator | the participants will only follow standard preventive measure twice a day brushing with fluoride toothpaste and flossing once a day Receives: Drug: standard preventive measures |
| antimicrobial and fluoride mouth wash | Active comparator | participants will use mouth wash contains both chlorhexidine and fluoride in addition to standard preventive measures Receives: Drug: antimicrobial and fluoride mouth wash |
| grape seeds extract mouth wash | Experimental | the intervention is grape seeds extract mouth wash Receives: Drug: Grape Seed Extract mouth wash |
What is being measured
The primary outcome is the main question the study is designed to answer.
caries incidence
visual inspection of new carious lesions
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 posted30 Oct 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Feb 2020 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Nader, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724578
- Sponsor's protocol ID
- 15102018
- Status last verified
- Oct 2018
- First submitted
- 28 Oct 2018
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grape Seeds Versus Standard Measures for Prevention of Caries Incidence in Young Egyptian Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03724578
- Acronym / sponsor ID
- 15102018
- Conditions
- Dental Caries
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 30 Oct 2018 (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.
The objective is to conduct an randomized controlled clinical trial to evaluate the effectiveness of grape seeds extract mouth wash in comparison with standard caries preventive measures for the prevention of new carious lesions in high caries risk patients.
This study will be designed to test the alternative hypothesis that using grape seed extract mouth wash in addition to standard preventive measures will show significant difference over using standard preventive measures alone in preventing incidence of new carious lesions in high caries risk patients
Detailed description
Research Question:
In high caries risk patients, will the incorporation of grape seeds extract after using standard oral hygiene measures be beneficial in reducing caries risk and preventing the incidence of new carious lesions?
Intervention:
The study will be announced at the Faculty of Oral and Dental Medicine, Future University campus to encourage interested students to participate in the study.
Interested participants will be screened at Conservative Department clinic for eligibility. Eligible participants will be assessed using caries risk assessment tool (American Dental Association caries risk assessment form).
Eligible participants will be randomly divided into three groups 1st group will follow only standard preventive measures (tooth brushing twice a day with fluoride tooth paste and inter-dental flossing once daily), 2nd group will use grape seeds extract mouth wash beside standard preventive measure, and 3rd group will use antimicrobial mouthwash with fluoride beside standard preventive measure General operative procedures Before starting the study the eligible participants will undergo scaling and prophylaxis polishing, then any carious cavity, or defective restoration will be treated and filled with resin composite restoration.
New set of manual brushes and dental floss will be given to the participants, after they are properly trained for the correct brushing and flossing technique. The participants will be asked to brush their teeth twice a day with fluoride tooth paste and to clean their teeth inter-dentally with dental floss once a day every day till the end of the study. All the participants will undergo scaling and prophylaxis polishing at every recall visit Preparation of the grape seeds extract mouthwash
- Procedure of preparing Grape Seed Extract:
Grape seeds will be collected from grapes which are available in the market. These seeds will be dried under sunlight for 2 days, and then these seeds will be grounded with cold pressure technique. Ground grape seeds (100 gm) will be extracted with ethanol/water ratio of 70:30, vol/vol, by maceration method under stirring at 45 degree centigrade for 2 hours, then The extract will be filtered(19).
For the intervention 1 group Beside the standard preventive measures that the participants will be trained to follow, each patient will be given a bottle of grape seeds extract mouthwash.
The participants will be instructed to rinse 15 milliliter of the mouthwash twice a day after breakfast and before bedtime and to retain it in their mouth for one minute before expectorating it, and not to consume any food or drink for 30 minutes after the use of mouthwash(12).
For intervention 2 group The participants will be instructed to rinse 15 milliliter of the mouth twice a day after breakfast and before bedtime and to retain it in their mouth for one minute before expectorating it, and not to consume any food or drink for 30 minutes after the use of mouthwash. Participants will repeat this protocol for five days every month until the end of the study.
For the control group Participants in this group will follow only the standard preventive measures which is brushing twice a day after breakfast and before bed time and daily flossing inter-dentally before bed time.
In all study groups if any patient during the period of the study develops any carious cavity, the affected tooth will be treated immediately and restored with resin composite restoration.
Outcomes:
Visual inspection to detect presence or absence of new caries lesions will be done according to World Health Organization guidelines. Caries detection will be carried out after careful drying of the tooth surface using three-way syringe to facilitate detection of initial enamel lesions (white spot lesions). Also pits and fissure carious lesions will be detected using visual and tactile method. (26).
Sample size:
The aim of this study is to assess Incidence of new caries in Grape seeds versus standard measures for prevention of caries. Based on a previous paper by Zhang 2006(27) the difference in caries development (reduction by antimicrobial mouth wash) between at least 2 groups is 40%. Using power 80% and 5% significance level the investigators will need to study 22 in each group. This number is to be increased to a sample size of 26 to compensate for losses during follow up. Sample size calculation was achieved using PS: Power and Sample Size Calculation software Version 3.1.2 (Vanderbilt University, Nashville, Tennessee, USA
Recruitment:
Patients will be recruited by (S.K and O.N) from the students of Faculty of Oral and Dental medicine, Future University as the research is targeting young Egyptian adults, only the eligible participants will be chosen until reaching the target sample size.
-Baseline data collection: For every patient medical and dental history and caries risk assessment profile will be obtained. Examination chart will be filled by (O.N)
Outcome data collection:
Visual caries inspection and community periodontal index probe(28) will be used by the assessor (S.K and E.A) after 3 months, 6 months, 9 months and 1 year to evaluate the presence or absence of new caries lesions.
Patient retention:
The patient's phone number will be recorded in their charts and before every visit the patient will receive a reminder call by (O.N). If the patient did not answer, another appointment will be scheduled within a week.
No harms are expected as the intervention product is natural product and Considered as (generally recognized as safe) by The FDA (Food and Drug Administration Informed consent The trial will be explained to the patients by the principle investigator. The researcher will discuss the interventions and possible harms with patients and obtain written consent (in Arabic) from the patients willing to participate in the trial. An appendix of the consent form is attached to the protocol
Post-trial care All patients will complete their treatment by the same operator at the clinic of the Conservative Department. The participants will be followed up even after the trial ends (6 months follow up period) to treat patient's complaints and prevent any possible complications
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard preventive measures | Sham comparator | Drug: standard preventive measuresthe participants will only follow standard preventive measure twice a day brushing with fluoride toothpaste and flossing once a day |
| antimicrobial and fluoride mouth wash | Active comparator | Drug: antimicrobial and fluoride mouth washparticipants will use mouth wash contains both chlorhexidine and fluoride in addition to standard preventive measures |
| grape seeds extract mouth wash | Experimental | Drug: Grape Seed Extract mouth washthe intervention is grape seeds extract mouth wash |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- patients with High caries risk
- 18-25 years
- Males or females
- Medically free patients
- Patients approving to participate in the study
Key exclusion criteria (8 listed)
- • Patients were on antibiotic therapy or corticosteroid therapy for 30 days before the examination
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 |
|---|---|---|
| Grape Seed Extract mouth washparticipants will use grape seeds extract mouth wash in addition to standard preventive measures | Drug | grape seeds extract mouth wash |
| standard preventive measurestwice daily brushing with fluoride tooth pate and daily flossing | Drug | standard preventive measures |
| antimicrobial and fluoride mouth washusing chlorhexidine and fluoride containing mouth wash | Drug | antimicrobial and fluoride mouth wash |
Primary outcome
caries incidence
Time frame: 12 months
visual inspection of new carious lesions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Individual participant dataSharing planned: No
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Grape Seed Extract mouth wash, standard preventive measures and antimicrobial and fluoride mouth wash in people with Dental Caries, run by Cairo 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 5 inclusion and 8 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 2 Nov 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact omar na galal, masters (+201155343399, dr.omar-nader@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
caries incidence (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2018.