Poor Aesthetics of Existing RestorationNCT02999880
Layering Technique Selection for Ultimate Aesthetics in Anterior Composites
A study testing Polychromatic layering in people with Poor Aesthetics of Existing Restoration, run by Cairo University.
Trial summary
the importance of this study is to evaluate the clinical performance of direct anterior resin composite restoration constructed using innovative esthetic dual-shade technique and another restoration constructed using polychromatic natural layering technique with various finishing and polishing steps. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Poor Aesthetics of Existing Restoration
- What is being tested?
- Polychromatic layering
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to Sep 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with good general health.
- Patients who will agree to the consent and will commit to follow-up period.
- Fully erupted anterior teeth with defects.
- Active caries, fractures, or defective Restorations in 6 anterior teeth.
- At least one spot lesion for contra-lateral anterior teeth on each side in the same jaw
Who cannot join
- Patients with any systemic disease that may affect normal healing.
- Patient with bad oral hygiene.
- Tetracycline or florsis staining.
- Patients who could/would not participate in all times of follow-up.
- Untreated periodontal disease was not allowed.
- Patients participating in more than 1 dental study.
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- Patient received fluoride varnish during orthodontic treatment.
- Fully erupted anterior teeth with no defects.
- Patients with tendency to do bleaching during the study.
About this study
Official title: Clinical Performance of Direct Anterior Composite Restorations Using Innovative Esthetic Dual-Shade Versus Polychromatic Natural Layering Technique Randomized Clinical Trial
the importance of this study is to evaluate the clinical performance of direct anterior resin composite restoration constructed using innovative esthetic dual-shade technique and another restoration constructed using polychromatic natural layering technique with various finishing and polishing steps.
The benefit from carrying out this study is to help the practitioners to decide the most suitable, easy, perfect technique to provide an optimally aesthetic, long lasting with superior clinical performance direct anterior resin composite restoration.
Read the detailed description
-Study setting: Study is to be conducted in the Conservative Dentistry Department - Cairo University.
- Interventions:
- Preoperative clinical assessment: (O.S) will diagnose and select patients according to inclusion and exclusion criteria. He will record all base line data with understanding of patients' chief complains and aesthetic needs after treatment. Moreover, he will provide guidance for patients to prepare for the study.
- (A.H) and (G.Z) will take standard preoperative digital photographs before intervention by modifying mobile camera with smile lite (made in Switzerland) and smile capture 2016 contain 10 adaptors to allow connection between smile lite and the smartphone then photos will be saved in a computer.
- (A.H) and (G.Z) will take color shade using both Vita shade guide and Vita-Easy shade compact.
- .(A.H) and (G.Z) will ask patient for his satisfaction will be taken by visual analogue scale (0-100mm), 0 score refer to not satisfied at all, while 100 score refer to totally satisfied.
- (G.Z) and (A.H) will carry out all these tests at baseline, immediately after, 6 and 12 months in post-operative follow-up visits.
- Pre-operative planning (O.S) will be responsible for randomization according to patient selection for the sealed envelope containing which half will receive the control and the other will receive the intervention (Split mouth technique). Control group will be performed using polychromatic composite layering technique .Intervention group will be performed using dual shade composite layering technique.
- Intraoperative procedure: (G.Z) will do the following procedures:
- Silicone matrix will be fabricated either directly in the patient mouth using lingual surface of the remaining tooth structure and the existing restorations as a guide ,or fabricated on a study cast after optimizing the shape and function of the teeth with a wax up.
- Teeth preparation: after complete removal of caries a 1.5mm 75° functional- esthetic enamel bevel will prepared using 8888 diamond bur ( Brasseler, Savannah, GA, USA) on the facial surface, the lingual bevel will be 45° functional bevel, then a coarse disc (sof-lex,3M ESPE) will be used to extend the facial bevel where needed interproximally and toward the gingival third of the facial surface.
- Cleaning the teeth surface with fluoride-free paste(Depurdent, Dr Wild AG) and water.
- Teflon tape will placed on the adjacent teeth to prevent there being etched.
Application of each material is done according to the manufacture instructions:
- Application of 32% phosphoric acid (Uni-Etch,Bisco,Schaumburg, IL,USA) to enamel and dentine for 15 seconds.
- The acid etchant will then rinsed for 30 seconds, excess water will be eliminated and dental adhesive ( Adper Single Bond 2, 3M ESPE))will be applied.
- The silicon matrix will be seated followed by application of the lingual layer of composite( Filtek Supreme Ultra Universal Restorative[3M ESPE]) to form the lingual shell and after light curing the first increment the silicone matrix and Teflon tape will be removed.
Dual-shade layering (Intervention):
Only two composite resin material shades will be used (opaque dentine composite and enamel shade composite).
Polychromatic layering (Control):
Using and mixing different composite shades, opalescents and intensives.
- Finishing and polishing: will be performed using all grates of sof-lex discs (sof-lex,3M ESPE) , fine and Extra fine diamond burs (Brasseler), finishing strips, medium and fine rubber polishing points( Jiffy Polishers, Ultradent).
- Postoperative procedure:
- Patient satisfaction: using Visual analogue scale (0-100mm), 0 score refer to not satisfied at all, while 100 score refer to totally satisfied.
- Digital photographs using digital camera
- Color shade using Vita Easy shade:
- Clinical evaluation using FDI criteria: (A.H) and (G.Z) will record all result outcomes on the following duration: immediately after, 6 and 12 months in post-operative follow-up visits.
- Conditions
- Poor Aesthetics of Existing Restoration
- Being tested
- Polychromatic layering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polychromatic layeringProcedure or surgery
Only two composite resin material shades will be used (opaque dentine composite and enamel shade composite).
| Study group | Role | What they receive |
|---|---|---|
| Polychromatic layering (Control): | Experimental | Using and mixing different composite shades, opalescents and intensives. Receives: Procedure: Polychromatic layering |
| Dual-shade layering (Intervention): | No intervention | Only two composite resin material shades the opaque dentin composite and enamel shade composite. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Scale 0-100 cm, 0 is unsatisfied at all, 100 satisfied totally.
Measured: Change in satisfaction from baseline, after6 months and 0ne year
Secondary outcomes (1)
Color shade
Numerical
Measured: change in shade from baseline, after six months and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startJul 2017
- Primary completionJul 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Aesthetics of Existing RestorationStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Ahmed Elzayat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999880
- Sponsor's protocol ID
- CEBD-CU-2016-10-237
- Status last verified
- Dec 2016
- First submitted
- 8 Dec 2016
- Last updated
- 21 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Direct Anterior Composite Restorations Using Innovative Esthetic Dual-Shade Versus Polychromatic Natural Layering Technique Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02999880
- Acronym / sponsor ID
- CEBD-CU-2016-10-237
- Conditions
- Poor Aesthetics of Existing Restoration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2017
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 21 Dec 2016 (estimated)
- 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 importance of this study is to evaluate the clinical performance of direct anterior resin composite restoration constructed using innovative esthetic dual-shade technique and another restoration constructed using polychromatic natural layering technique with various finishing and polishing steps.
The benefit from carrying out this study is to help the practitioners to decide the most suitable, easy, perfect technique to provide an optimally aesthetic, long lasting with superior clinical performance direct anterior resin composite restoration.
Detailed description
-Study setting: Study is to be conducted in the Conservative Dentistry Department - Cairo University.
- Interventions:
- Preoperative clinical assessment: (O.S) will diagnose and select patients according to inclusion and exclusion criteria. He will record all base line data with understanding of patients' chief complains and aesthetic needs after treatment. Moreover, he will provide guidance for patients to prepare for the study.
- (A.H) and (G.Z) will take standard preoperative digital photographs before intervention by modifying mobile camera with smile lite (made in Switzerland) and smile capture 2016 contain 10 adaptors to allow connection between smile lite and the smartphone then photos will be saved in a computer.
- (A.H) and (G.Z) will take color shade using both Vita shade guide and Vita-Easy shade compact.
- .(A.H) and (G.Z) will ask patient for his satisfaction will be taken by visual analogue scale (0-100mm), 0 score refer to not satisfied at all, while 100 score refer to totally satisfied.
- (G.Z) and (A.H) will carry out all these tests at baseline, immediately after, 6 and 12 months in post-operative follow-up visits.
- Pre-operative planning (O.S) will be responsible for randomization according to patient selection for the sealed envelope containing which half will receive the control and the other will receive the intervention (Split mouth technique). Control group will be performed using polychromatic composite layering technique .Intervention group will be performed using dual shade composite layering technique.
- Intraoperative procedure: (G.Z) will do the following procedures:
- Silicone matrix will be fabricated either directly in the patient mouth using lingual surface of the remaining tooth structure and the existing restorations as a guide ,or fabricated on a study cast after optimizing the shape and function of the teeth with a wax up.
- Teeth preparation: after complete removal of caries a 1.5mm 75° functional- esthetic enamel bevel will prepared using 8888 diamond bur ( Brasseler, Savannah, GA, USA) on the facial surface, the lingual bevel will be 45° functional bevel, then a coarse disc (sof-lex,3M ESPE) will be used to extend the facial bevel where needed interproximally and toward the gingival third of the facial surface.
- Cleaning the teeth surface with fluoride-free paste(Depurdent, Dr Wild AG) and water.
- Teflon tape will placed on the adjacent teeth to prevent there being etched.
Application of each material is done according to the manufacture instructions:
- Application of 32% phosphoric acid (Uni-Etch,Bisco,Schaumburg, IL,USA) to enamel and dentine for 15 seconds.
- The acid etchant will then rinsed for 30 seconds, excess water will be eliminated and dental adhesive ( Adper Single Bond 2, 3M ESPE))will be applied.
- The silicon matrix will be seated followed by application of the lingual layer of composite( Filtek Supreme Ultra Universal Restorative[3M ESPE]) to form the lingual shell and after light curing the first increment the silicone matrix and Teflon tape will be removed.
Dual-shade layering (Intervention):
Only two composite resin material shades will be used (opaque dentine composite and enamel shade composite).
Polychromatic layering (Control):
Using and mixing different composite shades, opalescents and intensives.
- Finishing and polishing: will be performed using all grates of sof-lex discs (sof-lex,3M ESPE) , fine and Extra fine diamond burs (Brasseler), finishing strips, medium and fine rubber polishing points( Jiffy Polishers, Ultradent).
- Postoperative procedure:
- Patient satisfaction: using Visual analogue scale (0-100mm), 0 score refer to not satisfied at all, while 100 score refer to totally satisfied.
- Digital photographs using digital camera
- Color shade using Vita Easy shade:
- Clinical evaluation using FDI criteria: (A.H) and (G.Z) will record all result outcomes on the following duration: immediately after, 6 and 12 months in post-operative follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polychromatic layering (Control): | Experimental | Procedure: Polychromatic layeringUsing and mixing different composite shades, opalescents and intensives. |
| Dual-shade layering (Intervention): | No intervention | –Only two composite resin material shades the opaque dentin composite and enamel shade composite. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
Key exclusion criteria (9 listed)
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 |
|---|---|---|
| Polychromatic layeringOnly two composite resin material shades will be used (opaque dentine composite and enamel shade composite). | Procedure or surgery | Polychromatic layering (Control): |
Primary outcome
Patient satisfaction
Time frame: Change in satisfaction from baseline, after6 months and 0ne year
Scale 0-100 cm, 0 is unsatisfied at all, 100 satisfied totally.
1 secondary outcome
Color shade
Time frame: change in shade from baseline, after six months and one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2016.
- 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 Polychromatic layering in people with Poor Aesthetics of Existing Restoration, 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 9 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 21 Dec 2016. 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?
Patient satisfaction (time frame: Change in satisfaction from baseline, after6 months and 0ne 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 21 Dec 2016.