Class II Caries in PremolarsAutomatrixNCT01662388
A Clinical Trial of Proximal Composite Restorations
A study testing Separation ring and automatrix band in people with Class II Caries in Premolars, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Several techniques have been advocated to get good contacts in dental composite restorations including interdental separation ring. The investigators study focuses on using separation ring with circumferential matrix band instead of a sectional band. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Class II Caries in Premolars
- What is being tested?
- Separation ring and automatrix band
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 sitePakistan
- Study dates
- Nov 2007to Dec 2011
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients who had supra gingival Class II cavities in permanent premolars. Teeth with cavity isthmus less than one-third of intercuspal distance were inducted
Who cannot join
- Partially erupted teeth, teeth with non-carious tooth surface wear or with orthodontic bands or brackets or whose adjacent tooth continuous with the cavity side is missing were excluded.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Dental Clinics, Aga Khan University Hospital
Karachi, Sindh, 74800
About this study
Several techniques have been advocated to get good contacts in dental composite restorations including interdental separation ring. The investigators study focuses on using separation ring with circumferential matrix band instead of a sectional band. Moreover, the investigators have attempted to study proximal tightness and proximal contours of composite restoration as separate variables
Read the detailed description
A total of 188 premolar teeth with proximal cavity to be assigned on alternate basis in two groups. Intervention group teeth received Automatrix band after cavity preparation followed by the separation ring using clamp while the control group received Automatrix band alone.
All teeth to be restored with P-60 composite restorative material(3M-ESPE Dental, USA). Outcome (proximal tightness) is determined by a blinded assessor just after the restoration.
- Conditions
- Class II Caries in Premolars
- Being tested
- Separation ring, automatrix band
- Keywords
- proximal caries, composite restoration, proximal contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Separation ringDevice
Also called BiTine® Separation ring by Palodent, product # 659040)
Separation ring placed along with automatrix band
automatrix bandDevice
Also called circumferential automatrix band by Dentsply
band placed with a tightening device
| Study group | Role | What they receive |
|---|---|---|
| automatrix band, Separation ring | Experimental | The prepared teeth received Automatrix band (similar to the control group, product code# 62422513). The Automatrix was burnished against the adjacent tooth gently. Anatomical wedges were applied in the proximal area and then the separation ring (BiTine® round ring by Palodent systems, Dentsply International, DE, USA product # 659040) placed with the help of retainer forceps. Receives: Device: Separation ring; Device: automatrix band |
| automatrix band | Active comparator | Teeth received Automatrix band alone (Wide-Regular type, dimensions 7.9 mm height and 0.05mm thickness, product code # 62422513). It was secured on the prepared tooth and burnished against the adjacent tooth gently. Anatomical wedges were placed in the inter-proximal area gingival to the cavity preparation. Receives: Device: automatrix band |
What is being measured
The primary outcome is the main question the study is designed to answer.
proximal tightness
The tightness of the proximal contact area resulting from either of the two matrix band system. It was measured using a nine inch long nylon dental floss (Johnson and Johnson, USA).
Measured: 1 day (just after dental restoration)
Secondary outcomes (1)
proximal contours
To be examined clinically with an explorer and mouth mirror and then on the periapical radiograph by the blinded co investigator.
Measured: 1 day (just after restoration placement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startNov 2007
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II Caries in PremolarsStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farhan Raza Khan, Aga Khan University
- Investigators
- Farhan R Khan, FCPS, Principal investigator, AKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662388
- Sponsor's protocol ID
- 640-Sur-ERC-06
- Other IDs
- 640-Sur/ERC-06
- Acronym
- Automatrix
- Status last verified
- Apr 2017
- First submitted
- 8 Aug 2012
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Proximal Composite Restorations
- ClinicalTrials.gov ID
- NCT01662388
- Acronym / sponsor ID
- Automatrix / 640-Sur-ERC-06
- Conditions
- Class II Caries in Premolars
- Keywords
- proximal caries, composite restoration, proximal contact
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Aug 2012 (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.
Several techniques have been advocated to get good contacts in dental composite restorations including interdental separation ring. The investigators study focuses on using separation ring with circumferential matrix band instead of a sectional band. Moreover, the investigators have attempted to study proximal tightness and proximal contours of composite restoration as separate variables
Detailed description
A total of 188 premolar teeth with proximal cavity to be assigned on alternate basis in two groups. Intervention group teeth received Automatrix band after cavity preparation followed by the separation ring using clamp while the control group received Automatrix band alone.
All teeth to be restored with P-60 composite restorative material(3M-ESPE Dental, USA). Outcome (proximal tightness) is determined by a blinded assessor just after the restoration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| automatrix band, Separation ring | Experimental | Device: Separation ring, Device: automatrix bandThe prepared teeth received Automatrix band (similar to the control group, product code# 62422513). The Automatrix was burnished against the adjacent tooth gently. Anatomical wedges were applied in the proximal area and then the separation ring (BiTine® round ring by Palodent systems, Dentsply International, DE, USA product # 659040) placed with the help of retainer forceps. |
| automatrix band | Active comparator | Device: automatrix bandTeeth received Automatrix band alone (Wide-Regular type, dimensions 7.9 mm height and 0.05mm thickness, product code # 62422513). It was secured on the prepared tooth and burnished against the adjacent tooth gently. Anatomical wedges were placed in the inter-proximal area gingival to the cavity preparation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who had supra gingival Class II cavities in permanent premolars. Teeth with cavity isthmus less than one-third of intercuspal distance were inducted
Key exclusion criteria (1 listed)
- Partially erupted teeth, teeth with non-carious tooth surface wear or with orthodontic bands or brackets or whose adjacent tooth continuous with the cavity side is missing were excluded.
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 |
|---|---|---|
| Separation ringAlso: BiTine® Separation ring by Palodent, product # 659040)Separation ring placed along with automatrix band | Device | automatrix band, Separation ring |
| automatrix bandAlso: circumferential automatrix band by Dentsplyband placed with a tightening device | Device | automatrix band, automatrix band, Separation ring |
Primary outcome
proximal tightness
Time frame: 1 day (just after dental restoration)
The tightness of the proximal contact area resulting from either of the two matrix band system. It was measured using a nine inch long nylon dental floss (Johnson and Johnson, USA).
1 secondary outcome
proximal contours
Time frame: 1 day (just after restoration placement)
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 20 Apr 2017.
Related trials for Class II Caries in Premolars
Active, not recruiting
Clinical Evaluation of a New Flowable and a New Sculptable Universal Bulk-fill Composite for Direct Restorative Treatment
Insufficient Dental Filling or Primary Caries (Class I or II Cavities in Premolars or Molars)
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.
Farhan R Khan, FCPS principal investigator
AKU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Separation ring and automatrix band in people with Class II Caries in Premolars, run by Aga Khan University at 1 site in Pakistan.
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 20 Apr 2017. 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 Pakistan. 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?
proximal tightness (time frame: 1 day (just after dental restoration)). 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 20 Apr 2017.