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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Jordan1 site
  • University of Jordan Hospital

    Amman, 11942

Other trials in Jordan

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.

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 groups in NCT04249726
Study groupRoleWhat they receive
Direct composite resin restorationExperimentalRoot 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 crownActive comparatorRoot 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.

  1. Survival

    Survival of the tooth and restoration

    Measured: 5 years

  2. Success

    Success of the restoration without complications: to be assessed based on modified USPHS criteria (margin integrity, color, surface texture)

    Measured: 5 years

  3. Complications

    Complications that affect the restoration

    Measured: 5 years

  4. 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.

  1. First posted31 Jan 2020
  2. Study start25 Jan 2019
  3. Primary completionJan 2024 (estimated)
  4. Study completionAug 2024 (estimated)

Resources

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)
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

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.

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