Dental Restoration Failure of Marginal IntegrityNCT05125900
Clinical Evaluation of Subgingival Open Sandwich Restorations
A study testing Proximal box elevation using one of the tested materials in people with Dental Restoration Failure of Marginal Integrity, run by Mansoura University at 1 site in Egypt.
Trial summary
This study was designed to evaluate and compare the 3-year periodontal responses and clinical performance of proximal subgingival open sandwich restorations using three different glass ionomer-based restorative materials and flowable composite. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Restoration Failure of Marginal Integrity
- What is being tested?
- Proximal box elevation using one of the tested materials
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 1 Jan 2023
- 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with one proximal sub gingival carious lesion ICDAS 4, or 5 in posterior teeth
- Patients must have a good oral hygiene;
- Patients with tooth gives positive response to testing with an electric pulp tester
- Patients with normal and full occlusion,
- Patients with opposing teeth should be natural with no restorations.
Who cannot join
- High caries risk patients with extremely poor oral hygiene,
- Patients involved in orthodontic treatment or periodontal surgery,
- Patients with periodontally involved teeth (chronic periodontitis)
- Patients with abutments should be excluded.
- Patients with heavy bruxism habits and clenching
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry-Mansoura University
Al Mansurah, Dakahliya, 35516
About this study
Official title: Clinical Evaluation of Subgingival Open Sandwich Restorations: 3-year Results of a Randomized Double-blind Trial
This study was designed to evaluate and compare the 3-year periodontal responses and clinical performance of proximal subgingival open sandwich restorations using three different glass ionomer-based restorative materials and flowable composite.
Read the detailed description
The description of the experimental design followed the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study was a double-blinded (patients and examiner) randomized clinical trial anticipating the parallel design. Ninety-five adult patients seeking dental treatment in the Operative Department clinic at the Faculty of Dentistry, University of Mansoura were enrolled in the current study with a total of 120 Class II restorations. No advertisement was made for participant recruitment, forming a sample of convenience. Each patient must signs a consent form before participating in the current study. The study was conducted from January 2020 to January 2023 as a part of the Doctoral dissertation. Mansoura University institution's ethics committee approved the form and protocol before conducting the study. The sample size was calculated based on the clinical success rate (100% success rate at 2 years) of posterior class II restorations restored with open sandwich and deep margin elevation techniques observed in previous studies. According to several parameters including a significance level of 5%, the power of the test was calculated to be 80%, and equivalent limit of 15%. Upon these data, a sample size of 120 subjects was appropriate to allow for a 20% drop-out.
- Being tested
- Proximal box elevation using one of the tested materials
- Keywords
- Deep margin elevation, Proximal box elevation, Open sandwich technique, Bi-layered restorations, Subgingival cervical margin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal box elevation using one of the tested materialsOther
Each patient randomly received deep proximal margin elevation with one of the tested restorative materials, while the overlying restorations were all the same regular bulk fill resin composite
| Study group | Role | What they receive |
|---|---|---|
| Resin modified glass ionomer | Active comparator | Group received proximal box elevation using resin modified glass ionomer Receives: Other: Proximal box elevation using one of the tested materials |
| Glass hybrid | Placebo comparator | Group received proximal box elevation using glass hybrid Receives: Other: Proximal box elevation using one of the tested materials |
| Bulk fill flowable resin composite | Active comparator | Group received proximal box elevation using bulk fill flowable resin composite Receives: Other: Proximal box elevation using one of the tested materials |
| Ion-releasing material | Placebo comparator | Group received proximal box elevation using ion-releasing material Receives: Other: Proximal box elevation using one of the tested materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with periodontal problems
The periodontal situation of patients were examined based on bleeding on probing, plaque index and probing depth scores
Measured: 3 years after restoration
Percentage of aesthetic, functional and biological properties for each base material restorations
Percentage of aesthetic, functional and biological properties were clinically assessed using World Dental Federation parameters for each base material group
Measured: 3 years after restoration
Secondary outcomes (1)
Radiographic examination
Each base material/gingival dentin interface was examined radiographically each 6 months period.
Measured: 3 years after restoration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start1 Jan 2020
- Primary completion1 Jan 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Restoration Failure of Marginal IntegrityStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Model description
- Each patient received one or two restorations in a posterior tooth on any side randomly selected from the 4 tested restorative materials, all materials were used according to manufacturers' instructions
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hoda S Ismail, Lecturer, Principal investigator, Faculty of Dentistry, Mansoura University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125900
- Sponsor's protocol ID
- A01111219
- Status last verified
- Jul 2023
- First submitted
- 8 Nov 2021
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol, Statistical Analysis Plan can be shared to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Subgingival Open Sandwich Restorations: 3-year Results of a Randomized Double-blind Trial
- ClinicalTrials.gov ID
- NCT05125900
- Acronym / sponsor ID
- A01111219
- Keywords
- Deep margin elevation, Proximal box elevation, Open sandwich technique, Bi-layered restorations, Subgingival cervical margin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 18 Nov 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 study was designed to evaluate and compare the 3-year periodontal responses and clinical performance of proximal subgingival open sandwich restorations using three different glass ionomer-based restorative materials and flowable composite.
Detailed description
The description of the experimental design followed the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study was a double-blinded (patients and examiner) randomized clinical trial anticipating the parallel design. Ninety-five adult patients seeking dental treatment in the Operative Department clinic at the Faculty of Dentistry, University of Mansoura were enrolled in the current study with a total of 120 Class II restorations. No advertisement was made for participant recruitment, forming a sample of convenience. Each patient must signs a consent form before participating in the current study. The study was conducted from January 2020 to January 2023 as a part of the Doctoral dissertation. Mansoura University institution's ethics committee approved the form and protocol before conducting the study. The sample size was calculated based on the clinical success rate (100% success rate at 2 years) of posterior class II restorations restored with open sandwich and deep margin elevation techniques observed in previous studies. According to several parameters including a significance level of 5%, the power of the test was calculated to be 80%, and equivalent limit of 15%. Upon these data, a sample size of 120 subjects was appropriate to allow for a 20% drop-out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Each patient received one or two restorations in a posterior tooth on any side randomly selected from the 4 tested restorative materials, all materials were used according to manufacturers' instructions
| Arm | Type | Receives |
|---|---|---|
| Resin modified glass ionomer | Active comparator | Other: Proximal box elevation using one of the tested materialsGroup received proximal box elevation using resin modified glass ionomer |
| Glass hybrid | Placebo comparator | Other: Proximal box elevation using one of the tested materialsGroup received proximal box elevation using glass hybrid |
| Bulk fill flowable resin composite | Active comparator | Other: Proximal box elevation using one of the tested materialsGroup received proximal box elevation using bulk fill flowable resin composite |
| Ion-releasing material | Placebo comparator | Other: Proximal box elevation using one of the tested materialsGroup received proximal box elevation using ion-releasing material |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with one proximal sub gingival carious lesion ICDAS 4, or 5 in posterior teeth
- Patients must have a good oral hygiene;
- Patients with tooth gives positive response to testing with an electric pulp tester
- Patients with normal and full occlusion,
- Patients with opposing teeth should be natural with no restorations.
Key exclusion criteria (5 listed)
- High caries risk patients with extremely poor oral hygiene,
- Patients involved in orthodontic treatment or periodontal surgery,
- Patients with periodontally involved teeth (chronic periodontitis)
- Patients with abutments should be excluded.
- Patients with heavy bruxism habits and clenching
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 |
|---|---|---|
| Proximal box elevation using one of the tested materialsEach patient randomly received deep proximal margin elevation with one of the tested restorative materials, while the overlying restorations were all the same regular bulk fill resin composite | Other | Bulk fill flowable resin composite, Glass hybrid, Ion-releasing material, Resin modified glass ionomer |
Primary outcome
Percentage of patients with periodontal problems
Time frame: 3 years after restoration
The periodontal situation of patients were examined based on bleeding on probing, plaque index and probing depth scores
Percentage of aesthetic, functional and biological properties for each base material restorations
Time frame: 3 years after restoration
Percentage of aesthetic, functional and biological properties were clinically assessed using World Dental Federation parameters for each base material group
1 secondary outcome
Radiographic examination
Time frame: 3 years after restoration
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 14 Jul 2023.
- Individual participant dataSharing planned: Yes. Study Protocol, Statistical Analysis Plan can be shared to other researchers
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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.
Hoda S Ismail, Lecturer principal investigator
Faculty of Dentistry, Mansoura University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proximal box elevation using one of the tested materials in people with Dental Restoration Failure of Marginal Integrity, run by Mansoura 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 5 inclusion and 5 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 14 Jul 2023. 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. Some participants in this study may receive a placebo. 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?
Percentage of patients with periodontal problems (time frame: 3 years after restoration). The study lists 2 primary outcomes in all. 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 14 Jul 2023.