Endodontically Treated TeethNCT04249726
The Restoration of Endodontically Treated Teeth Using Indirect Full Coverage Restorations Compared to Direct Composite Resin Restorations
A study testing Direct composite resin restoration and Direct composite resin restoration followed by full coverage metal ceramic crown in people with Endodontically Treated Teeth, run by University of Jordan at 1 site in Jordan.
Trial summary
The use of full cuspal coverage restoration for the management root treated teeth was advocated by many clinical studies and supported by systematic reviews. However, most of the studies did not take into account the amount of tooth structure remaining before providing cuspal coverage. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endodontically Treated Teeth
- What is being tested?
- Direct composite resin restoration and Direct composite resin restoration followed by full coverage metal ceramic crown
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteJordan
- Study dates
- 25 Jan 2019to Aug 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To have at least one posterior tooth in need for root canal treatment and restoration.
- The tooth structure loss of the tooth should be limited to an occlusal cavity with at least three remaining axial walls (>2mm thickness).
- The tooth should be opposed by a natural tooth or a fixed partial denture.
- The tooth should not be serving as an abutment for a removal or fixed partial denture.
Who cannot join
- Patients under 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Restoration of Minimally Destructed Posterior Endodontically Treated Teeth Using Indirect Full Coverage Restorations Compared to Direct Composite Resin Restorations: A Randomised Clinical Trial.
The use of full cuspal coverage restoration for the management root treated teeth was advocated by many clinical studies and supported by systematic reviews. However, most of the studies did not take into account the amount of tooth structure remaining before providing cuspal coverage. The strength and fracture resistance of the tooth has been shown to be positively correlated with the amount of tooth structure remaining. A more conservative treatment option could be selected for a root treated tooth with good amount of remaining tooth structure such as direct restorations.
The aims of this randomized clinical trial is to compare the survival and success of root treated teeth with occlusal cavities and at least three intact axial walls, when restored through the use of indirect full cuspal coverage restorations vs direct composite resin restorations.
Read the detailed description
The management of posterior endodontically treated teeth (ETT) is still to this day considered a controversial topic.The use of full cuspal coverage restoration for the management ETT was advocated by many clinical studies and supported by systematic reviews. However, most of the studies did not take into account the amount of tooth structure remaining before providing cuspal coverage. An ETT tooth with an MOD cavity will be at a higher risk of fracture than an ETT tooth with just an occlusal cavity. Managing both with cuspal coverage could be considered an overtreatment and an unnecessary removal of tooth structure. The strength and fracture resistance of the tooth has been shown to be positively correlated with the amount of tooth structure remaining. A more conservative treatment option could be selected for an ETT with good amount of remaining tooth structure such as direct restorations.
The aims of this randomized clinical trial is to compare the survival and success of ETT with occlusal cavities and at least three intact axial walls, when restored through the use of indirect full cuspal coverage restorations vs direct composite resin restorations.
The groups are:
Group 1: Managed with direct intracoronal composite resin restoration. Group 2: Managed with a direct composite resin restoration, followed by an indirect full coverage restoration.
Patients will be recalled at 1 year, 3 years and 5 years.
Treatment protocol for each group Group 1: Patient receiving a composite resin restoration. Following rubber dam isolation, the temporary restoration will be removed. The enamel will be selectively etched with 37% phosphoric acid and rinsed and dried thoroughly till a white frost appearance appeared. An adhesive system (ScotchBond Multi-Purpose - 3M ESPE) will then be applied to the dentine according to the manufacturer instructions and then will be cured for 30 seconds. The direct restoration will be made using a microhybrid resin composite (Filtek Z350, 3M ESPE), which will be applied in increments and each increment cured for 40 seconds. Glycerin will be applied to the final restoration and cured for 5 seconds to prevent the development of the oxygen inhibition layer. The restoration will then be finished with ultra-fine diamond finishing burs, and polished with Sof-Lex discs (3M ESPE) and 0.1 micrometer particle size diamond paste. Occlusion will be checked to conform to the patient's current occlusion status and make sure no interferences were introduced.
Group 2: Patients receiving a composite resin restoration and followed with an indirect full coverage restoration.
The same steps used as for group 1 would be followed to build the composite resin core. This will be followed with a preparation for the indirect full cuspal restoration. Three additional silicone putty indices will be made; one will be made for the production of a provisional crown, and the other two will be cut and used as reduction indices (one will be cut mesio-distally and the other one will be cut facially-lingually/palatally). The preparation will be carried out with diamond burs. The guidelines to be followed will include:
- Supra or equigingival margins if aesthetic was of concern.
- Chamfer finish-line
- 2 mm occlusal reduction;
- 1.5 mm axial reduction all around Following the application of two double retraction cord sizes 00 and 0 (Ultradent), the impression will be made with additional silicone (Zermack) and the cast poured in Die stone. The crown will be fabricated in the laboratory.
The temporary crown made from self-cure bisacrylic (Protemp, 3M ESPE) would be cemented using Eugenol free temporary crown and bridge cement (TempBond). All crowns will be cemented after 1 week using Resin modified glass ionomer cement (RelyX luting plus, 3M ESPE).
Follow-up appointments and data Collection
Clinical evaluation will include:
- Visual inspection conducted with loops at magnification 4.5
- Examination of the continuity of the margins of the restoration with the tooth structure by use of an explorer
- Periodontal probing performed with a periodontal probe.
- Color photos (1:1 mirror shots) of the restorations were taken with standard film
- Periapical and bitewing radiographic examination was performed by use of a paralleling technique at 65 kV and 8 mA.
- Patients reported outcome measures (PROM)
Evaluation of success or failure will be performed by 2 examiners other than the operator.
- Conditions
- Endodontically Treated Teeth
- Being tested
- Direct composite resin restoration, Direct composite resin restoration followed by full coverage metal ceramic crown
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct composite resin restorationProcedure or surgery
Also called Intracoronal restoration
A direct composite resin restoration will be provided intracoronally without cuspal coverage.
Direct composite resin restoration followed by full coverage metal ceramic crownProcedure or surgery
Also called Full coverage metal-ceramic crown
A direct composite resin restoration will be provided intracoronally followed by a full cuspal coverage metal ceramic crown.
| Study group | Role | What they receive |
|---|---|---|
| Direct composite resin restoration | Experimental | Root filled teeth with occlusal cavities and at least 3 intact axial walls will receive composite resin restorations Receives: Procedure: Direct composite resin restoration |
| Full coverage metal-ceramic crown | Active comparator | Root filled teeth with occlusal cavities and at least 3 intact axial walls will receive composite resin restorations followed by full coverage metal-ceramic crown Receives: Procedure: Direct composite resin restoration followed by full coverage metal ceramic crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Survival of the tooth and restoration
Measured: 5 years
Success
Success of the restoration without complications: to be assessed based on modified USPHS criteria (margin integrity, color, surface texture)
Measured: 5 years
Complications
Complications that affect the restoration
Measured: 5 years
Patient reported satisfaction
Patients' reported satisfaction with the restoration provided regarding: appearance, function, ease of cleaning and cost using the visual analog scale.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start25 Jan 2019
- Primary completionJan 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontically Treated TeethStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups parallel to each other randomly assigned to a specific intervention.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Motasum Abu-Awwad, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249726
- Sponsor's protocol ID
- UJordan1
- Status last verified
- Jul 2023
- First submitted
- 24 Jan 2020
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Restoration of Minimally Destructed Posterior Endodontically Treated Teeth Using Indirect Full Coverage Restorations Compared to Direct Composite Resin Restorations: A Randomised Clinical Trial.
- ClinicalTrials.gov ID
- NCT04249726
- Acronym / sponsor ID
- UJordan1
- Conditions
- Endodontically Treated Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 31 Jan 2020 (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 use of full cuspal coverage restoration for the management root treated teeth was advocated by many clinical studies and supported by systematic reviews. However, most of the studies did not take into account the amount of tooth structure remaining before providing cuspal coverage. The strength and fracture resistance of the tooth has been shown to be positively correlated with the amount of tooth structure remaining. A more conservative treatment option could be selected for a root treated tooth with good amount of remaining tooth structure such as direct restorations.
The aims of this randomized clinical trial is to compare the survival and success of root treated teeth with occlusal cavities and at least three intact axial walls, when restored through the use of indirect full cuspal coverage restorations vs direct composite resin restorations.
Detailed description
The management of posterior endodontically treated teeth (ETT) is still to this day considered a controversial topic.The use of full cuspal coverage restoration for the management ETT was advocated by many clinical studies and supported by systematic reviews. However, most of the studies did not take into account the amount of tooth structure remaining before providing cuspal coverage. An ETT tooth with an MOD cavity will be at a higher risk of fracture than an ETT tooth with just an occlusal cavity. Managing both with cuspal coverage could be considered an overtreatment and an unnecessary removal of tooth structure. The strength and fracture resistance of the tooth has been shown to be positively correlated with the amount of tooth structure remaining. A more conservative treatment option could be selected for an ETT with good amount of remaining tooth structure such as direct restorations.
The aims of this randomized clinical trial is to compare the survival and success of ETT with occlusal cavities and at least three intact axial walls, when restored through the use of indirect full cuspal coverage restorations vs direct composite resin restorations.
The groups are:
Group 1: Managed with direct intracoronal composite resin restoration. Group 2: Managed with a direct composite resin restoration, followed by an indirect full coverage restoration.
Patients will be recalled at 1 year, 3 years and 5 years.
Treatment protocol for each group Group 1: Patient receiving a composite resin restoration. Following rubber dam isolation, the temporary restoration will be removed. The enamel will be selectively etched with 37% phosphoric acid and rinsed and dried thoroughly till a white frost appearance appeared. An adhesive system (ScotchBond Multi-Purpose - 3M ESPE) will then be applied to the dentine according to the manufacturer instructions and then will be cured for 30 seconds. The direct restoration will be made using a microhybrid resin composite (Filtek Z350, 3M ESPE), which will be applied in increments and each increment cured for 40 seconds. Glycerin will be applied to the final restoration and cured for 5 seconds to prevent the development of the oxygen inhibition layer. The restoration will then be finished with ultra-fine diamond finishing burs, and polished with Sof-Lex discs (3M ESPE) and 0.1 micrometer particle size diamond paste. Occlusion will be checked to conform to the patient's current occlusion status and make sure no interferences were introduced.
Group 2: Patients receiving a composite resin restoration and followed with an indirect full coverage restoration.
The same steps used as for group 1 would be followed to build the composite resin core. This will be followed with a preparation for the indirect full cuspal restoration. Three additional silicone putty indices will be made; one will be made for the production of a provisional crown, and the other two will be cut and used as reduction indices (one will be cut mesio-distally and the other one will be cut facially-lingually/palatally). The preparation will be carried out with diamond burs. The guidelines to be followed will include:
- Supra or equigingival margins if aesthetic was of concern.
- Chamfer finish-line
- 2 mm occlusal reduction;
- 1.5 mm axial reduction all around Following the application of two double retraction cord sizes 00 and 0 (Ultradent), the impression will be made with additional silicone (Zermack) and the cast poured in Die stone. The crown will be fabricated in the laboratory.
The temporary crown made from self-cure bisacrylic (Protemp, 3M ESPE) would be cemented using Eugenol free temporary crown and bridge cement (TempBond). All crowns will be cemented after 1 week using Resin modified glass ionomer cement (RelyX luting plus, 3M ESPE).
Follow-up appointments and data Collection
Clinical evaluation will include:
- Visual inspection conducted with loops at magnification 4.5
- Examination of the continuity of the margins of the restoration with the tooth structure by use of an explorer
- Periodontal probing performed with a periodontal probe.
- Color photos (1:1 mirror shots) of the restorations were taken with standard film
- Periapical and bitewing radiographic examination was performed by use of a paralleling technique at 65 kV and 8 mA.
- Patients reported outcome measures (PROM)
Evaluation of success or failure will be performed by 2 examiners other than the operator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups parallel to each other randomly assigned to a specific intervention.
| Arm | Type | Receives |
|---|---|---|
| Direct composite resin restoration | Experimental | Procedure: Direct composite resin restorationRoot filled teeth with occlusal cavities and at least 3 intact axial walls will receive composite resin restorations |
| Full coverage metal-ceramic crown | Active comparator | Procedure: Direct composite resin restoration followed by full coverage metal ceramic crownRoot filled teeth with occlusal cavities and at least 3 intact axial walls will receive composite resin restorations followed by full coverage metal-ceramic crown |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To have at least one posterior tooth in need for root canal treatment and restoration.
- The tooth structure loss of the tooth should be limited to an occlusal cavity with at least three remaining axial walls (>2mm thickness).
- The tooth should be opposed by a natural tooth or a fixed partial denture.
- The tooth should not be serving as an abutment for a removal or fixed partial denture.
Key exclusion criteria (1 listed)
- Patients under 18
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 |
|---|---|---|
| Direct composite resin restorationAlso: Intracoronal restorationA direct composite resin restoration will be provided intracoronally without cuspal coverage. | Procedure or surgery | Direct composite resin restoration |
| Direct composite resin restoration followed by full coverage metal ceramic crownAlso: Full coverage metal-ceramic crownA direct composite resin restoration will be provided intracoronally followed by a full cuspal coverage metal ceramic crown. | Procedure or surgery | Full coverage metal-ceramic crown |
Primary outcome
Survival
Time frame: 5 years
Survival of the tooth and restoration
Success
Time frame: 5 years
Success of the restoration without complications: to be assessed based on modified USPHS criteria (margin integrity, color, surface texture)
Complications
Time frame: 5 years
Complications that affect the restoration
Patient reported satisfaction
Time frame: 5 years
Patients' reported satisfaction with the restoration provided regarding: appearance, function, ease of cleaning and cost using the visual analog scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct composite resin restoration and Direct composite resin restoration followed by full coverage metal ceramic crown in people with Endodontically Treated Teeth, run by University of Jordan at 1 site in Jordan.
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 4 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: status not confirmed, as of the sponsor's last update on 5 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 Jordan. 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?
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?
Survival (time frame: 5 years). The study lists 4 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 5 Jul 2023.