Class V Dental CariesNCT04944485
One Year Clinical Performance of Self Adhesive Giomer Containing Flowable Composite in Restoring Class V Cavities
A study testing (FIT SA F03, SHOFU, USA) and (Neo Spectra™ ST, Dentsply, Sirona, USA) in people with Class V Dental Caries and Composite Resin and Self Adhesive Flowable Composite, run by Cairo University.
Trial summary
This clinical trial will be conducted to compare the clinical performance of self adhesive giomer containing flowable composite and putty nanohybrid resin composite in class V cavities over one year follow-up Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Class V Dental Caries, Composite Resin and Self Adhesive Flowable Composite
- What is being tested?
- (FIT SA F03, SHOFU, USA) and (Neo Spectra™ ST, Dentsply, Sirona, USA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Aug 2021to Aug 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with carious anterior or posterior buccal class V lesions.
- No signs of irreversible pulpitis (vital teeth)
- Young adult males or females.
- . Acceptable oral hygiene.
- Co-operative patients approving to participate in the study
Who cannot join
- Patients with a compromised medical history.
- Severe or active periodontal disease
- Systemic diseases or severe medical complications (disabilities).
- Lack of compliance
- Extensive carious lesion that is in risk of pulp exposure.
- Rampant caries.
Show all 10Show fewer
- History of pain or swelling.
- Endodontically treated teeth.
- Mobility grade 1 or 2
- Non-carious cervical abfraction lesions
About this study
Official title: One Year Clinical Performance of Self Adhesive Giomer Containing Flowable Composite in Restoring Class V Cavities: A Randomized Clinical Trial
This clinical trial will be conducted to compare the clinical performance of self adhesive giomer containing flowable composite and putty nanohybrid resin composite in class V cavities over one year follow-up
Read the detailed description
This clinical trial will be conducted in Department of Conservative Dentistry, Faculty of Dentistry,Cairo university outpatient clinic. The Operator in charge will be: Salma Mohamed Monir (S.M).
The researcher will bear ultimate responsibility for all activities associated with the conduct of a research project including recruitment of patients, explaining and performing the procedures to the patients.
Screening of patients that come to the Conservative Dentistry Department Clinic seeking dental care will continue until the target population is achieved. The patients will be subjected to full examination and diagnosis using dental charts. Once the patients that are potentially eligible for this study are identified, the patients will be contacted by the research investigator (S.M) who will explain the study and ascertains the patient's interest. If interested, more detailed evaluations and preparations are made.
Randomization will be done using simple randomization by (N.K) by generating numbers from 1:100 into two columns according to interventions/Control assessment methods. The allocation sequence will be generated using (www.randomization.com) The randomization list will be kept with (N.K) and will be kept secured away to ensure no tampering with the random list. Each participant will choose a random number from an opaque sealed envelope. When the participant chooses an envelope, it will be signed by the patient and the supervisor and the number on the envelope will be recorded in the patient chart to ensure that the patient is assigned to the randomized group The assessors, statistician and the patients will be blinded to intervention/control assessment methods; Triple blinded study. Also, it will not be allowed amongst the examiners to exchange any information throughout the entire study period.
For every patient medical and dental history will be taken. Examination charts will be filled by the investigator S.M.
Informed consent:
Patients attending at the Department of Conservative Dentistry, Faculty of Dentistry, Cairo University will be screened. Those who meet the study inclusion criteria will be recruited, will be informed with the study and an informed consent will be signed if the patients approve.
Periodontal treatment:
Periodontal treatment will be made and oral hygiene instructions will be enforced. Then, the operator will start rubber-dam isolation and cavity preparation is done as follows:
Cavity preparation procedure:
Patients will be given local anesthesia as required, and the teeth will be isolated. A No. #330 bur (0.8 mm in diameter and 1.6 mm in length) in a high speed hand piece with air /water coolant will be used to prepare class V cavity preparations. Any tooth that will suffer from pulpal exposure will be excluded from the study. Remaining caries will be excavated by a sharp excavator. A 1mm bevel will be prepared in enamel margins (Folwaczny et al., 2001). According to the concealed envelope, the tooth will be assigned to one of both treatment groups.
Control group: Selective enamel etching will be done and a universal adhesive (Prime\&Bond universal™ ,Dentsply)will be applied to both enamel and dentin. After gentle dryness and solvent evaporation the bonding agent will be cured for 20 seconds. Composite (Neo Spectra™ST, Dentsply, Sirona, USA) will be placed incrementally and light cured for 20 seconds (Noé Orellana et al., 2009)
Intervention group: Cleaning and gentle air blowing of the preparation. Then applying FIT SA F03 (Low Flow), SHOFU, USA. Spread in a thin layer (≤0.5mm) on the prepared surface with needle tip, microbrush and gently air-blow leave for 20 seconds then light cure for 5 seconds. Then, apply additional increments (≤2mm) of FIT SA and light cure each increment for 10 seconds then finish and polish.
Post curing will be done using glycerin to decrease the oxygen inhibited layer (Strnad et al.,2015). Finishing will be done using yellow and white finishing stones. More finishing and polishing will be done. Rubber-dam will be removed and patients will be recalled for evaluation after 3, 6 and 12 months. A.R and Y.S will be blinded to both treatment groups. AR and Y.S will give the restorations a score using Modified USPHS score.
- Being tested
- (FIT SA F03, SHOFU, USA), (Neo Spectra™ ST, Dentsply, Sirona, USA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(FIT SA F03, SHOFU, USA)Other
Self adhesive giomer containing nanohybrid flowable composite
(Neo Spectra™ ST, Dentsply, Sirona, USA)Other
Conventional technique using putty nanohybrid resin composite
| Study group | Role | What they receive |
|---|---|---|
| class V cavities treated with putty nanohybrid resin composite | Active comparator | Selective enamel etching will be done and a universal adhesive (Prime\&Bond universal™ ,Dentsply)will be applied to both enamel and dentin. After gentle dryness and solvent evaporation the bonding agent will be cured for 20 seconds. Composite (Neo Spectra™ST, Dentsply, Sirona, USA) will be placed incrementally and light cured for 20 seconds Receives: Other: (Neo Spectra™ ST, Dentsply, Sirona, USA) |
| class V cavities treated with Self adhesive giomer containing nanohybrid flowable composite | Experimental | Cleaning and gentle air blowing of the preparation. Then applying FIT SA F03 (Low Flow), SHOFU, USA. Spread in a thin layer (≤0.5mm) on the prepared surface with needle tip, microbrush and gently air-blow leave for 20 seconds then light cure for 5 seconds. Then,apply additional increments (≤2mm) of FIT SA and light cure each increment for 10 seconds then finish and polish Receives: Other: (FIT SA F03, SHOFU, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing change in marginal discoloration between time points 3, 6 ,12 months
Visual inspection with mirror Alpha :There is no visual evidence of any marginal discoloration at the junction of the restoration and the adjacent tooth structure . Bravo :There is visual evidence of shallow marginal discoloration. Charlie : There is visual evidence of deep marginal discoloration toward a pulpal direction.
Measured: 3,6,12 months
Secondary outcomes (1)
Assessing change in modified USPHS criteria between time points 3, 6 ,12 months
visual inspection of postoperative hypersensitivity ,secondary caries, gross fracture,colour match , marginal integrity , anatomic contour and surface texture
Measured: 3,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study startAug 2021 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class V 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Mohamed Monir Mahmoud Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944485
- Sponsor's protocol ID
- 14422019423506
- Status last verified
- Jun 2021
- First submitted
- 21 Jun 2021
- Last updated
- 29 Jun 2021
- 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 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Year Clinical Performance of Self Adhesive Giomer Containing Flowable Composite in Restoring Class V Cavities: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04944485
- Acronym / sponsor ID
- 14422019423506
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 29 Jun 2021 (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 clinical trial will be conducted to compare the clinical performance of self adhesive giomer containing flowable composite and putty nanohybrid resin composite in class V cavities over one year follow-up
Detailed description
This clinical trial will be conducted in Department of Conservative Dentistry, Faculty of Dentistry,Cairo university outpatient clinic. The Operator in charge will be: Salma Mohamed Monir (S.M).
The researcher will bear ultimate responsibility for all activities associated with the conduct of a research project including recruitment of patients, explaining and performing the procedures to the patients.
Screening of patients that come to the Conservative Dentistry Department Clinic seeking dental care will continue until the target population is achieved. The patients will be subjected to full examination and diagnosis using dental charts. Once the patients that are potentially eligible for this study are identified, the patients will be contacted by the research investigator (S.M) who will explain the study and ascertains the patient's interest. If interested, more detailed evaluations and preparations are made.
Randomization will be done using simple randomization by (N.K) by generating numbers from 1:100 into two columns according to interventions/Control assessment methods. The allocation sequence will be generated using (www.randomization.com) The randomization list will be kept with (N.K) and will be kept secured away to ensure no tampering with the random list. Each participant will choose a random number from an opaque sealed envelope. When the participant chooses an envelope, it will be signed by the patient and the supervisor and the number on the envelope will be recorded in the patient chart to ensure that the patient is assigned to the randomized group The assessors, statistician and the patients will be blinded to intervention/control assessment methods; Triple blinded study. Also, it will not be allowed amongst the examiners to exchange any information throughout the entire study period.
For every patient medical and dental history will be taken. Examination charts will be filled by the investigator S.M.
Informed consent:
Patients attending at the Department of Conservative Dentistry, Faculty of Dentistry, Cairo University will be screened. Those who meet the study inclusion criteria will be recruited, will be informed with the study and an informed consent will be signed if the patients approve.
Periodontal treatment:
Periodontal treatment will be made and oral hygiene instructions will be enforced. Then, the operator will start rubber-dam isolation and cavity preparation is done as follows:
Cavity preparation procedure:
Patients will be given local anesthesia as required, and the teeth will be isolated. A No. #330 bur (0.8 mm in diameter and 1.6 mm in length) in a high speed hand piece with air /water coolant will be used to prepare class V cavity preparations. Any tooth that will suffer from pulpal exposure will be excluded from the study. Remaining caries will be excavated by a sharp excavator. A 1mm bevel will be prepared in enamel margins (Folwaczny et al., 2001). According to the concealed envelope, the tooth will be assigned to one of both treatment groups.
Control group: Selective enamel etching will be done and a universal adhesive (Prime\&Bond universal™ ,Dentsply)will be applied to both enamel and dentin. After gentle dryness and solvent evaporation the bonding agent will be cured for 20 seconds. Composite (Neo Spectra™ST, Dentsply, Sirona, USA) will be placed incrementally and light cured for 20 seconds (Noé Orellana et al., 2009)
Intervention group: Cleaning and gentle air blowing of the preparation. Then applying FIT SA F03 (Low Flow), SHOFU, USA. Spread in a thin layer (≤0.5mm) on the prepared surface with needle tip, microbrush and gently air-blow leave for 20 seconds then light cure for 5 seconds. Then, apply additional increments (≤2mm) of FIT SA and light cure each increment for 10 seconds then finish and polish.
Post curing will be done using glycerin to decrease the oxygen inhibited layer (Strnad et al.,2015). Finishing will be done using yellow and white finishing stones. More finishing and polishing will be done. Rubber-dam will be removed and patients will be recalled for evaluation after 3, 6 and 12 months. A.R and Y.S will be blinded to both treatment groups. AR and Y.S will give the restorations a score using Modified USPHS score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| class V cavities treated with putty nanohybrid resin composite | Active comparator | Other: (Neo Spectra™ ST, Dentsply, Sirona, USA)Selective enamel etching will be done and a universal adhesive (Prime\&Bond universal™ ,Dentsply)will be applied to both enamel and dentin. After gentle dryness and solvent evaporation the bonding agent will be cured for 20 seconds. Composite (Neo Spectra™ST, Dentsply, Sirona, USA) will be placed incrementally and light cured for 20 seconds |
| class V cavities treated with Self adhesive giomer containing nanohybrid flowable composite | Experimental | Other: (FIT SA F03, SHOFU, USA)Cleaning and gentle air blowing of the preparation. Then applying FIT SA F03 (Low Flow), SHOFU, USA. Spread in a thin layer (≤0.5mm) on the prepared surface with needle tip, microbrush and gently air-blow leave for 20 seconds then light cure for 5 seconds. Then,apply additional increments (≤2mm) of FIT SA and light cure each increment for 10 seconds then finish and polish |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with carious anterior or posterior buccal class V lesions.
- No signs of irreversible pulpitis (vital teeth)
- Young adult males or females.
- . Acceptable oral hygiene.
- Co-operative patients approving to participate in the study
Key exclusion criteria (10 listed)
- Patients with a compromised medical history.
- Severe or active periodontal disease
- Systemic diseases or severe medical complications (disabilities).
- Lack of compliance
- Extensive carious lesion that is in risk of pulp exposure.
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 |
|---|---|---|
| (FIT SA F03, SHOFU, USA)Self adhesive giomer containing nanohybrid flowable composite | Other | class V cavities treated with Self adhesive giomer containing nanohybrid flowable composite |
| (Neo Spectra™ ST, Dentsply, Sirona, USA)Conventional technique using putty nanohybrid resin composite | Other | class V cavities treated with putty nanohybrid resin composite |
Primary outcome
Assessing change in marginal discoloration between time points 3, 6 ,12 months
Time frame: 3,6,12 months
Visual inspection with mirror Alpha :There is no visual evidence of any marginal discoloration at the junction of the restoration and the adjacent tooth structure . Bravo :There is visual evidence of shallow marginal discoloration. Charlie : There is visual evidence of deep marginal discoloration toward a pulpal direction.
1 secondary outcome
Assessing change in modified USPHS criteria between time points 3, 6 ,12 months
Time frame: 3,6,12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing (FIT SA F03, SHOFU, USA) and (Neo Spectra™ ST, Dentsply, Sirona, USA) in people with Class V Dental Caries and Composite Resin and Self Adhesive Flowable Composite, 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 10 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 29 Jun 2021. 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?
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?
Assessing change in marginal discoloration between time points 3, 6 ,12 months (time frame: 3,6,12 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 29 Jun 2021.