Recurrent Caries IncidenceNCT03139409
Digital Radiography in Detection of Recurrent Caries Underneath Chlorhexidine Containing Adhesive Versus Conventional Adhesive After One Year Follow up: Randomized Clinical Trial
A study testing adhesive bond with chlorhexidine and Time variable in people with Recurrent Caries Incidence, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to compare the effect of chlorexidine containing adhesive versus conventional one in prevention of secondary caries lesion underneath composite restoration over one year follow up null hypothesis Read more about this study
- Who is it for?
- Ages 20 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Recurrent Caries Incidence
- What is being tested?
- adhesive bond with chlorhexidine and Time variable
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2017to 27 Jul 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 20 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients should be 20-25 years of age with high caries risk. Patients should have an acceptable oral hygiene level. Patients must have at least two proximal lesions to be restored.
Who cannot join
- Patients with a compromised medical history. Severe or active periodontal disease. Heavy bruxism or a traumatic occlusion. Lack of compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Radiography in Detection of Recurrent Caries Underneath Chlorhexidine Containing Adhesive Versus Conventional Adhesive After One Year Follow up.
This study will be conducted to compare the effect of chlorexidine containing adhesive versus conventional one in prevention of secondary caries lesion underneath composite restoration over one year follow up null hypothesis
Read the detailed description
each patient will have at least 2 class II cavities.one will be restored using the intervention and the other using the control.
Digital radiographs will be taken and the images will be processed using a digital system. Then the teeth will be evaluated by expert in dental radiology who had no awareness of the results of the visual inspection. The examiner will use a radiograph viewer and a radiographic film magnifier to determine the presence or absence of radiolucency underlying the restoration. The clinical and radiographic examination will be assessed according to the FDI World Dental Federation clinical criteria for the evaluation of direct and indirect restorations The aim of this equivalent trial is to examine if the chlorhexidine containing adhesive is effective as the conventional adhesive in prevention of recurrent caries under resin composite restoration after one year follow up in high caries risk patients with class II cavities. Based on the previous papers by Papagiannoulis et al .,1999 and kohler et al.,2000, the success rate reported was about 95% (absence of caries). If there is truly no difference between the standard and experimental treatment, then 37 patients are required to be 80% sure that the limits of a two-sided 90% confidence interval will exclude a difference between the standard and experimental group of more than 15 %. The sample size was calculated by sealed envelope online.
Data will be analyzed using IBM SPSS advanced statistics (statistical package for social sciences), version 21 ( SPSS Inc. Chicago , IL). Numerical data will be described as mean and standard deviation or median and range. Categorical data will be described as numbers and percentages. Comparisons between categorical variables will be performed using the chi square test. An equivalent limit will be tested. A P -value less than or equal 0.05 will be considered statistically significant. All tests will be two tailed
- Conditions
- Recurrent Caries Incidence
- Being tested
- adhesive bond with chlorhexidine, Time variable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adhesive bond with chlorhexidineProcedure or surgery
Also called peak universal bond
Peak® Universal Bond (ultradent, 505 West 10200 South, South Jordan, UT 84095،USA ) light-Cured Adhesive with Chlorhexidine (0.2%), 7.5% filler, phosphate and containing hydroxyethyl methacrylate with ethyl alcohol as the carrier. its viscosity has been optimized for minimal film thickness (2μm) and superior strength. using self etch adhesive with chlorexidine as one step in the bonding component may give chance to proper penetration of resin tags, decrease the micro-organisms due to the antibacterial effect of chlorexidine (Bin-Shuwaish, 2016) and also the addition of chlorexidine in bonding system may be an excellent tool to increase the stability of collagen fibrils within the hybrid layer against host-derived metaloproteinases (MMP) without the need for additional steps for the bonding protocol (Stanislawczuk, et al., 2009), which results in better durability and good restorations with decreasing the incidence of recurrent caries
Time variableOther
Diagnosis and follow up will be immediate , 6 months later and 1 year
| Study group | Role | What they receive |
|---|---|---|
| conventonal adhesive | Active comparator | peak lc bond Receives: Procedure: adhesive bond with chlorhexidine |
| Time variable | Other | Diagnosis and follow up will be immediate ,6 months later and 1 year Receives: Other: Time variable |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrent caries incidence
FDI clinical and radiographic criteria
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start20 Jul 2017
- Primary completion20 Jul 2018
- Study completion27 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Caries IncidenceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katreen Tawfik, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139409
- Sponsor's protocol ID
- CEBC-CU-2017-044-16
- Status last verified
- Jul 2019
- First submitted
- 30 Apr 2017
- Last updated
- 23 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Radiography in Detection of Recurrent Caries Underneath Chlorhexidine Containing Adhesive Versus Conventional Adhesive After One Year Follow up.
- ClinicalTrials.gov ID
- NCT03139409
- Acronym / sponsor ID
- CEBC-CU-2017-044-16
- Conditions
- Recurrent Caries Incidence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 27 Jul 2018 (actual)
- First posted
- 4 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.
This study will be conducted to compare the effect of chlorexidine containing adhesive versus conventional one in prevention of secondary caries lesion underneath composite restoration over one year follow up null hypothesis
Detailed description
each patient will have at least 2 class II cavities.one will be restored using the intervention and the other using the control.
Digital radiographs will be taken and the images will be processed using a digital system. Then the teeth will be evaluated by expert in dental radiology who had no awareness of the results of the visual inspection. The examiner will use a radiograph viewer and a radiographic film magnifier to determine the presence or absence of radiolucency underlying the restoration. The clinical and radiographic examination will be assessed according to the FDI World Dental Federation clinical criteria for the evaluation of direct and indirect restorations The aim of this equivalent trial is to examine if the chlorhexidine containing adhesive is effective as the conventional adhesive in prevention of recurrent caries under resin composite restoration after one year follow up in high caries risk patients with class II cavities. Based on the previous papers by Papagiannoulis et al .,1999 and kohler et al.,2000, the success rate reported was about 95% (absence of caries). If there is truly no difference between the standard and experimental treatment, then 37 patients are required to be 80% sure that the limits of a two-sided 90% confidence interval will exclude a difference between the standard and experimental group of more than 15 %. The sample size was calculated by sealed envelope online.
Data will be analyzed using IBM SPSS advanced statistics (statistical package for social sciences), version 21 ( SPSS Inc. Chicago , IL). Numerical data will be described as mean and standard deviation or median and range. Categorical data will be described as numbers and percentages. Comparisons between categorical variables will be performed using the chi square test. An equivalent limit will be tested. A P -value less than or equal 0.05 will be considered statistically significant. All tests will be two tailed
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventonal adhesive | Active comparator | Procedure: adhesive bond with chlorhexidinepeak lc bond |
| Time variable | Other | Other: Time variableDiagnosis and follow up will be immediate ,6 months later and 1 year |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients should be 20-25 years of age with high caries risk. Patients should have an acceptable oral hygiene level. Patients must have at least two proximal lesions to be restored.
Key exclusion criteria (1 listed)
- Patients with a compromised medical history. Severe or active periodontal disease. Heavy bruxism or a traumatic occlusion. Lack of compliance
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 |
|---|---|---|
| adhesive bond with chlorhexidineAlso: peak universal bondPeak® Universal Bond (ultradent, 505 West 10200 South, South Jordan, UT 84095،USA ) light-Cured Adhesive with Chlorhexidine (0.2%), 7.5% filler, phosphate and containing hydroxyethyl methacrylate with ethyl alcohol as the carrier. its viscosity has been optimized for minimal film thickness (2μm) and superior strength. using self etch adhesive with chlorexidine as one step in the bonding component may give chance to proper penetration of resin tags, decrease the micro-organisms due to the antibacterial effect of chlorexidine (Bin-Shuwaish, 2016) and also the addition of chlorexidine in bonding system may be an excellent tool to increase the stability of collagen fibrils within the hybrid layer against host-derived metaloproteinases (MMP) without the need for additional steps for the bonding protocol (Stanislawczuk, et al., 2009), which results in better durability and good restorations with decreasing the incidence of recurrent caries | Procedure or surgery | conventonal adhesive |
| Time variableDiagnosis and follow up will be immediate , 6 months later and 1 year | Other | Time variable |
Primary outcome
recurrent caries incidence
Time frame: 1 year
FDI clinical and radiographic criteria
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 23 Jul 2019.
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 adhesive bond with chlorhexidine and Time variable in people with Recurrent Caries Incidence, 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 1 inclusion and 1 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 23 Jul 2019. 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?
recurrent caries incidence (time frame: 1 year). 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 23 Jul 2019.