Class 2 Dental CavityNCT05386498
Comparison of Proximal Contacts and Contours in Class II Composite Restoration With Pre-cured Composite Inserts Versus Contact Making Instrument Technique. A Randomized Control Clinical Trial.
A study testing precured composite insert technique, Contact making instrument and Incremental composite layering technique in people with Class 2 Dental Cavity, run by Foundation University Islamabad.
Trial summary
The objective of this randomized control cinical trial will be to compare the effectiveness of precured composite inserts in obtaining tight and adequate conatacts in class 2 restorations when compared with the contact making instrument technique among patients treated at the operative depatment of Foundation… Read more about this study
- Who is it for?
- Ages 12 to 55 years
- Conditions the study is for
- Class 2 Dental Cavity
- What is being tested?
- precured composite insert technique, Contact making instrument and Incremental composite layering technique
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 31 Mar 2024
- 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 12 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patient requiring treatment for class 2 cavity
- patient age 12 to 55 years
- Maxillary and Mandibular first and second premolar
- Maxillary and Mandibular first and second molar
- Maximum occlusal cavo surface width of 2/3rd of intercuspal width
- Cavity depth upto 3/4th of occlusocervical length measured from diagnostic radiograph
- Teeth with adjacent fully erupted teeth adjacent to a cavity side Exclusion criteria
- 1)Mentally and physically handicapped patient 2)Pregnant females 3)Patients with naturally spaced teeth 4)Patients with moderate or advanced periodontitis 5)Endodontically treated teeth 6)Teeth with excessive occlusal wear and erosion of teeth 7)Tooth adjacent to cavity side is missing 8)Teeth with orhtodontic bands and brackets 9)Tooth adjacent to cavity side is restored
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
The objective of this randomized control cinical trial will be to compare the effectiveness of precured composite inserts in obtaining tight and adequate conatacts in class 2 restorations when compared with the contact making instrument technique among patients treated at the operative depatment of Foundation Umiversity College of Dentistry.
This is a single centre based randomized control clinical trial in which intervention arm 1 will get there class 2 restoration done with precured composite inserts and interention arm 2 will recieve treatment with contact making instrument technique. The control arm will recieve restoration using the conventional composite layering technique.
Read the detailed description
Study design : randomized control clinical trial with three intervention arms
Study setting : operative department , foundation university college of dentistry Islamabad Pakistan.
Sample size : the sample size was calculated using the NCSS PASS software. A total od 180 patients will be tested in the study divided in three groups of 60 patients each. Consent will be taken from pateints on a standardized form approved by the ethics review committe in the operatory where the initial assessment will be done.
Procedure:
- number of operaters will be restricted two, with similar level of experience in order to minimize operater variation
- the investigator and co investigator will calibrate each other on the sequence of the procedure and assessment to enhance standardization of procedure
- local anaesthesia will be given to patients using lidocaine 2% solution available for dental use in 1.8 ml carpule
- rubber dam will used for isolation and moisture control in the working field.
- the tooth to be restored will be seperated from the adjacent tooth using wooden wedges.this will allow seperation of teeth.
- cavity preparation will be done using a high speed handpiece(W\&H) with a round bur(prima) (no1/6 or 1/4). After initial penetration through enamel the carious lesion will be excavated using a a carbide bur in a slow speed handpiece. after caries removal any unsupported enamel at the gingival floor will be removed using a gingival margin trimmer. the cavity shape will be finalized using a pear shaped bur(243).
- the width of the final cavity will be measured using a perio probe from the buccal or labial cavo surface margin. Only cavities with less than 1/2 the width of the distance or less from the buccal or lingual cusp tip will be included in the study.
- sectional metal matrix (unimatrix by TDV Brazil,1/4" by 0.0015,1/4" by.002,height and thickness of matrix) will be applied after removing the previously placed wooden wedges. The wedges will be reintroduced after sectional matrix application.
- the cavity will be etched using 37% phosphoric acid etchant(30 seconds enamel and 15 seconds dentine) followed by rinsing for 30 seconds with the triple syringe. the cavity will be gently air dried while keep a dried cotton pellet in the cavity to absorb excess moisure for 30 to 45 seconds.Prime and Bond NT (Dentsply) adhesive will be applied to the cavity followed by curing for 20 seconds with an led based curing light (O-light,DTE wavelength of 400nm visible blue light). The cavities in all intervention arms will be restored with neo spectre NT composite(dentsply). (the detail of each intervention arm is given under their respective headings)
- after the cavities are filled the matrix band and the wedges will be removed.the cavity will be finished using diamond burs and composite finishing spirals(azdent). occlusal adjustment will be done where needed using articulating paper.
- the final restoration will be polished using diamond polishing paste(ultradent) and goat hair brushes (ultradent)
Assessment
- assessment will be done by passing waxed dental floss between the filling and adjacent tooth by a single independent assessor blinded to the treatment allocation.
- outcome will be assessed using the contact tightness and contour component of the modified USPHS rating scale
- data collection will be done at the end of the treatment using a printed porforma for recording the study variables.
Data analysis
- will be done using spss 26
- for continouse variables like age and cavity wifth and depth , mean and standard deviations will be computed. comparison of these variable will be done by one way anova test
- for categorical variables like gender, type of tooth,location of cavity,contact tightness and contour(outcome variables) frequencies in percentages will be reported. these variables will be compared using kruskal-wallis test at 0.05 level of significance
- Conditions
- Class 2 Dental Cavity
- Being tested
- precured composite insert technique, Contact making instrument, Incremental composite layering technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
precured composite insert techniqueProcedure or surgery
After curing of bonding agent a 2mm increment of composite will be placed on the gingival floor of the cavity and cured. a measured volume of composite(3mm height and 2mm width) will be cured outside the oral cavity on a flat plastic instrument for 40 seconds. a second increment of composite will be placed on the cavity and the precured composite will be pressed in the uncured increment and pressed outward against the matrix band and light cured for 20 seconds the rest of the cavity will be filled using the oblique layering technique.
Contact making instrumentProcedure or surgery
a 1-2mm increment of the composite will be placed in the gingival floor of the proxial box.
a contact forming instrument will be placed in this uncured increment and an outward force will be applied using the instrument from the inside of the matrix band. The composite will then be cured for 20 seconds to achieve a tight contact.
Incremental composite layering techniqueProcedure or surgery
Increments will be placed in 1-2mm increments in oblique layering manner by a flat plastic instrument and condenser .Each increment will be cured for 20 seconds till the cavity is slightly overfilled.
| Study group | Role | What they receive |
|---|---|---|
| Precure composite insert technique | Experimental | After curing of bonding agent a 2mm increment of composite will be placed on the gingival floor of the cavity and cured. a measured volume of composite(3mm height and 2mm width) will be cured outside the oral cavity on a flat plastic instrument for 40 seconds. a second increment of composite will be placed on the cavity and the precured composite will be pressed in the uncured increment and pressed outward against the matrix band and light cured for 20 seconds the rest of the cavity will be filled using the oblique layering technique. Receives: Procedure: precured composite insert technique |
| Contact Making Instrument | Experimental | a 1-2mm increment of the composite will be placed in the gingival floor of the proxial box.
a contact forming instrument will be placed in this uncured increment and an outward force will be applied using the instrument from the inside of the matrix band. The composite will then be cured for 20 seconds to achieve a tight contact. Receives: Procedure: Contact making instrument |
| Incremental composite layering technique | Active comparator | Increments will be placed in 1-2mm increments in oblique layering manner by a flat plastic instrument and condenser .Each increment will be cured for 20 seconds till the cavity is slightly overfilled. Receives: Procedure: Incremental composite layering technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contact tightness and Contour of Class 2 composite restoration
The contact tightness and contour of the filling will be assessed using the modified united states public health service system rating scale which has is used in studies on dental materials.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start1 Dec 2022 (estimated)
- Primary completion30 Mar 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class 2 Dental CavityStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- Model description
- The study is a single centre based randomized control trial where the intervention arm 1 will get their class 2 restorations done with precured composte insert technique. The intervention arm 2 will recieve treatment with contact making instrument technique. The intervention arm 3 patients will be the control group and will recieve treatment of their class 2 restoration with the incremental composite layering techique. The study will be conducted on patients seeking class 2 restorations at the operative department of foundation university college of dentistry. Allocation of the patients in treatment groups will be done by simple randomization using the lottery method.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386498
- Sponsor's protocol ID
- FUI/CTR/2022/7
- Status last verified
- May 2022
- First submitted
- 18 May 2022
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Proximal Contacts and Contours in Class II Composite Restoration With Pre-cured Composite Inserts Versus Contact Making Instrument Technique. A Randomized Control Clinical Trial.
- ClinicalTrials.gov ID
- NCT05386498
- Acronym / sponsor ID
- FUI/CTR/2022/7
- Conditions
- Class 2 Dental Cavity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 23 May 2022 (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 of this randomized control cinical trial will be to compare the effectiveness of precured composite inserts in obtaining tight and adequate conatacts in class 2 restorations when compared with the contact making instrument technique among patients treated at the operative depatment of Foundation Umiversity College of Dentistry.
This is a single centre based randomized control clinical trial in which intervention arm 1 will get there class 2 restoration done with precured composite inserts and interention arm 2 will recieve treatment with contact making instrument technique. The control arm will recieve restoration using the conventional composite layering technique.
Detailed description
Study design : randomized control clinical trial with three intervention arms
Study setting : operative department , foundation university college of dentistry Islamabad Pakistan.
Sample size : the sample size was calculated using the NCSS PASS software. A total od 180 patients will be tested in the study divided in three groups of 60 patients each. Consent will be taken from pateints on a standardized form approved by the ethics review committe in the operatory where the initial assessment will be done.
Procedure:
- number of operaters will be restricted two, with similar level of experience in order to minimize operater variation
- the investigator and co investigator will calibrate each other on the sequence of the procedure and assessment to enhance standardization of procedure
- local anaesthesia will be given to patients using lidocaine 2% solution available for dental use in 1.8 ml carpule
- rubber dam will used for isolation and moisture control in the working field.
- the tooth to be restored will be seperated from the adjacent tooth using wooden wedges.this will allow seperation of teeth.
- cavity preparation will be done using a high speed handpiece(W\&H) with a round bur(prima) (no1/6 or 1/4). After initial penetration through enamel the carious lesion will be excavated using a a carbide bur in a slow speed handpiece. after caries removal any unsupported enamel at the gingival floor will be removed using a gingival margin trimmer. the cavity shape will be finalized using a pear shaped bur(243).
- the width of the final cavity will be measured using a perio probe from the buccal or labial cavo surface margin. Only cavities with less than 1/2 the width of the distance or less from the buccal or lingual cusp tip will be included in the study.
- sectional metal matrix (unimatrix by TDV Brazil,1/4" by 0.0015,1/4" by.002,height and thickness of matrix) will be applied after removing the previously placed wooden wedges. The wedges will be reintroduced after sectional matrix application.
- the cavity will be etched using 37% phosphoric acid etchant(30 seconds enamel and 15 seconds dentine) followed by rinsing for 30 seconds with the triple syringe. the cavity will be gently air dried while keep a dried cotton pellet in the cavity to absorb excess moisure for 30 to 45 seconds.Prime and Bond NT (Dentsply) adhesive will be applied to the cavity followed by curing for 20 seconds with an led based curing light (O-light,DTE wavelength of 400nm visible blue light). The cavities in all intervention arms will be restored with neo spectre NT composite(dentsply). (the detail of each intervention arm is given under their respective headings)
- after the cavities are filled the matrix band and the wedges will be removed.the cavity will be finished using diamond burs and composite finishing spirals(azdent). occlusal adjustment will be done where needed using articulating paper.
- the final restoration will be polished using diamond polishing paste(ultradent) and goat hair brushes (ultradent)
Assessment
- assessment will be done by passing waxed dental floss between the filling and adjacent tooth by a single independent assessor blinded to the treatment allocation.
- outcome will be assessed using the contact tightness and contour component of the modified USPHS rating scale
- data collection will be done at the end of the treatment using a printed porforma for recording the study variables.
Data analysis
- will be done using spss 26
- for continouse variables like age and cavity wifth and depth , mean and standard deviations will be computed. comparison of these variable will be done by one way anova test
- for categorical variables like gender, type of tooth,location of cavity,contact tightness and contour(outcome variables) frequencies in percentages will be reported. these variables will be compared using kruskal-wallis test at 0.05 level of significance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The study is a single centre based randomized control trial where the intervention arm 1 will get their class 2 restorations done with precured composte insert technique. The intervention arm 2 will recieve treatment with contact making instrument technique. The intervention arm 3 patients will be the control group and will recieve treatment of their class 2 restoration with the incremental composite layering techique. The study will be conducted on patients seeking class 2 restorations at the operative department of foundation university college of dentistry. Allocation of the patients in treatment groups will be done by simple randomization using the lottery method.
| Arm | Type | Receives |
|---|---|---|
| Precure composite insert technique | Experimental | Procedure: precured composite insert techniqueAfter curing of bonding agent a 2mm increment of composite will be placed on the gingival floor of the cavity and cured. a measured volume of composite(3mm height and 2mm width) will be cured outside the oral cavity on a flat plastic instrument for 40 seconds. a second increment of composite will be placed on the cavity and the precured composite will be pressed in the uncured increment and pressed outward against the matrix band and light cured for 20 seconds the rest of the cavity will be filled using the oblique layering technique. |
| Contact Making Instrument | Experimental | Procedure: Contact making instrumenta 1-2mm increment of the composite will be placed in the gingival floor of the proxial box. a contact forming instrument will be placed in this uncured increment and an outward force will be applied using the instrument from the inside of the matrix band. The composite will then be cured for 20 seconds to achieve a tight contact. |
| Incremental composite layering technique | Active comparator | Procedure: Incremental composite layering techniqueIncrements will be placed in 1-2mm increments in oblique layering manner by a flat plastic instrument and condenser .Each increment will be cured for 20 seconds till the cavity is slightly overfilled. |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- patient requiring treatment for class 2 cavity
- patient age 12 to 55 years
- Maxillary and Mandibular first and second premolar
- Maxillary and Mandibular first and second molar
- Maximum occlusal cavo surface width of 2/3rd of intercuspal width
Key exclusion criteria (0 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 |
|---|---|---|
| precured composite insert techniqueAfter curing of bonding agent a 2mm increment of composite will be placed on the gingival floor of the cavity and cured. a measured volume of composite(3mm height and 2mm width) will be cured outside the oral cavity on a flat plastic instrument for 40 seconds. a second increment of composite will be placed on the cavity and the precured composite will be pressed in the uncured increment and pressed outward against the matrix band and light cured for 20 seconds the rest of the cavity will be filled using the oblique layering technique. | Procedure or surgery | Precure composite insert technique |
| Contact making instrumenta 1-2mm increment of the composite will be placed in the gingival floor of the proxial box. a contact forming instrument will be placed in this uncured increment and an outward force will be applied using the instrument from the inside of the matrix band. The composite will then be cured for 20 seconds to achieve a tight contact. | Procedure or surgery | Contact Making Instrument |
| Incremental composite layering techniqueIncrements will be placed in 1-2mm increments in oblique layering manner by a flat plastic instrument and condenser .Each increment will be cured for 20 seconds till the cavity is slightly overfilled. | Procedure or surgery | Incremental composite layering technique |
Primary outcome
Contact tightness and Contour of Class 2 composite restoration
Time frame: 1 day
The contact tightness and contour of the filling will be assessed using the modified united states public health service system rating scale which has is used in studies on dental materials.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing precured composite insert technique, Contact making instrument and Incremental composite layering technique in people with Class 2 Dental Cavity, run by Foundation University Islamabad.
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 8 inclusion and 0 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 23 May 2022. 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?
Contact Dr. Mansoor Khan, BDS,FCPS (+923345080923, mansoor.khan@fui.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contact tightness and Contour of Class 2 composite restoration (time frame: 1 day). 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 May 2022.