Endodontically Treated TeethNCT04518371
Clinical Performance of Milled Resin Composite in Restoration of Endodontically Treated Posterior Teeth Over One Year
A study testing Reinforced composite for the fabrication of permanent, indirect restorations using a CAD/CAM grinding process. in people with Endodontically Treated Teeth, run by Cairo University at 1 site in Egypt.
Trial summary
In patients with endodontically treated teeth, will the Indirect Milled composite Endo-crown restorations have a better clinical performance and more wear resistance than the Direct Bulk-Fill resin composite restorations over one year? Primary Objective: To evaluate clinical performance of different Techniques of… Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Endodontically Treated Teeth
- What is being tested?
- Reinforced composite for the fabrication of permanent, indirect restorations using a CAD/CAM grinding process.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Oct 2020to 28 Apr 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 16 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with asymptomatic endodontically treated molars.
- Males or Females.
- Good oral hygiene.
- Co-operative patients approving to participate in the study.
- Asymptomatic endodontically treated upper or lower molars with
- Homogenous root canal filling ending 1-2mm from the radiographic apex.
- Proximal compound cavities.
- Favorable occlusion.
Who cannot join
- High caries index with poor oral hygiene.
- Severe medical complications.
- Pregnancy.
- Allergic history concerning methacrylates Disabilities.
- Heavy smoking.
- Xerostomia.
Show all 14Show fewer
- Lack of compliance.
- Evidence of parafunctional habits.
- Temporomandibular joint disorders.
- Teeth with remaining wall thickness less than 1mm.
- Teeth with improper or symptomatic endodontic treatment.
- Deep subgingival cavity margins.
- Possible future prosthodontic restoration of teeth.
- Severe periodontal problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance and Wear Resistance of Milled Resin Composite Material Versus Direct Nanohybrid Bulk-Fill Resin Composite in Restoration of Endodontically Treated Posterior Teeth Over One Year: Randomized Clinical Trial
In patients with endodontically treated teeth, will the Indirect Milled composite Endo-crown restorations have a better clinical performance and more wear resistance than the Direct Bulk-Fill resin composite restorations over one year?
Primary Objective: To evaluate clinical performance of different Techniques of Composite Restorations (Indirect restorations using a CAD/CAM grinding process, BRILLIANT Crios, Coltène/Whaledent AG, Switzerland or Direct a light-cured, bulk-fill nanocomposite restorative material, Filtek™ One Bulk Fill Restorative, 3M ESPE Dental Products, USA) in Endodontically treated posterior teeth.
Read the detailed description
The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University; The operator in charge will be Esraa Esmeail Hussien.
Null-hypothesis: There are no differences in the clinical performance of indirect CAD/CAM milled composite when compared to direct bulk-fil composite endocrowns when in the posterior area.
Aim: This clinical trial will be conducted to assess the clinical performance of using indirect Milled composite or direct bulk-fill resin composite Endo-crowns for restoring the endo-treated teeth, as well to measure the amount of wear on the occlusal tables of both restorations using Digital Scanner.
Patients will be selected from the outpatient clinic of the department Conservative Dentistry Department, Faculty of Dentistry, Cairo University
Clinical Steps:
- A tapered stone with rounded end in a high-speed handpiece with air /water coolant will be used to properly prepare the cavity walls to receive the indirect restoration and any remaining carious dentin will be excavated and removed.
- Cuspal tipping will be done by a wheel stone about 1.5-2mm.
- The entrance to the pulpal canal will be opened. Gutta percha will be removed to a depth not exceeding 2 mm to take advantage of the saddle-like anatomy of the cavity floor. This should be done with a nonabrasive instrument to maintain the integrity of the canal's entrance. No drilling into the dentin will be carried out.
- Any remaining undercuts will be blocked with conventional resin composite.
- The impression will be taken, and the final restoration will be fabricated either direct or indirect.
- The final restoration should be checked intraorally for proximal contacts, occlusion and marginal fit before cementation.
- Isolation of operatory field using rubber dam.
- Selective enamel etching technique will be applied for bonding of tooth structure, 35-40% phosphoric acid gel will be applied to the enamel margins only for 15 seconds, rinsed for 15 seconds and gently dried by cotton pellet.
- Adhesive will be used according to the manufacturers' instructions.
- Adhesive resin cement will be applied into the preparation. The restoration will be placed in the cavity and checked for complete seating. The cement will be light cured for only 2 seconds to facilitate removal of the excess. Then light curing will be done from all directions each for 40 seconds for achieving the final set.
- The proximal contacts will be checked with dental floss.
- The occlusion will be adjusted using articulating paper.
- Finishing and Polishing using finishing stones and polishing rubber points.
Primary Objective: To evaluate clinical performance of different Techniques of Composite Restorations (Indirect restorations using a CAD/CAM grinding process, BRILLIANT Crios, Coltène/Whaledent AG, Switzerland or Direct a light-cured, bulk-fill nanocomposite restorative material, Filtek™ One Bulk Fill Restorative, 3M ESPE Dental Products, USA) in Endodontically treated posterior teeth.
- Conditions
- Endodontically Treated Teeth
- Being tested
- Reinforced composite for the fabrication of permanent, indirect restorations using a CAD/CAM grinding process.
- Keywords
- Endodontically Treated Teeth, Milled Composite, Clinical Performance, Occlusal Wear, IntraOral Scanner
- Medical subject headings
- Tooth, Nonvital, Tooth Attrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reinforced composite for the fabrication of permanent, indirect restorations using a CAD/CAM grinding process.Other
Also called CAD/CAM Composite endo-crown
Shock-absorbing effect due to the dentine-like modulus of elasticity makes BRILLIANT Crios extremely well suited for implant restorations.it is composed of dental glass (barium glass ˂ 1.0 μm), amorphous silica (Sio2 ˂ 20 nm), resin matrix (cross-linked methacrylates) and pigments
| Study group | Role | What they receive |
|---|---|---|
| Indirect Restoration | Experimental | Milled Resin Composite Block, Shock-absorbing effect due to the dentine-like modulus of elasticity makes BRILLIANT Crios extremely well suited for implant restorations.it is composed of dental glass (barium glass ˂ 1.0 μm), amorphous silica (Sio2 ˂ 20 nm), resin matrix (cross-linked methacrylates) and pigments (inorganic pigments such as ferrous oxide or titanium dioxide). Receives: Other: Reinforced composite for the fabrication of permanent, indirect restorations using a CAD/CAM grinding process. |
| Direct Restoration | Active comparator | 3M™ Filtek™ One Bulk Fill Restorative is a visible light activated, restorative composite optimized to create fast and easy restorations.
It is composed of fillers which are a combination of a non-agglomerated/non-aggregated 20 nm silica filler, 4 to 11 nm zirconia filler, zirconia/silica cluster filler and ytterbium trifluoride filler consisting of 100nm particles. The inorganic filler loading is about 76.5% by weight (58.5% by volume). Receives: Other: Reinforced composite for the fabrication of permanent, indirect restorations using a CAD/CAM grinding process. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Continuity between natural tooth structure and the restoration
Tactile sensation checking the anatomic form to show if there is no discontinuity, Slight discontinuity, or discontinuity and failure
Measured: Immediately after procedure
Degree of Continuity between natural tooth structure and the restoration
Tactile sensation checking the anatomic form to show if there is no discontinuity, Slight discontinuity, or discontinuity and failure
Measured: 6 months
Degree of Continuity between natural tooth structure and the restoration
Tactile sensation checking the anatomic form to show if there is no discontinuity, Slight discontinuity, or discontinuity and failure
Measured: 12 months
Secondary outcomes (15)
The degree of mismatch from the normal range of tooth shades and translucency
Visual inspection to check the proximity of the shade from the natural tooth
Measured: Immediately after procedure
The degree of mismatch from the normal range of tooth shades and translucency
Visual inspection to check the proximity of the shade from the natural tooth
Measured: 6 months
The degree of mismatch from the normal range of tooth shades and translucency
Visual inspection to check the proximity of the shade from the natural tooth
Measured: 12 months
Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time
Measured: Immediately after procedure
Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time
Measured: 6 months
Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time
Measured: 12 months
Pain due to dentin hypersensitivity (evaporative stimulus)
Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale
Measured: Immediately after procedure
Pain due to dentin hypersensitivity (evaporative stimulus)
Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale
Measured: 6 months
Pain due to dentin hypersensitivity (evaporative stimulus)
Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale
Measured: 12 months
Area of continuous movement of an explorer across the surface of the restoration
Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface
Measured: Immediately after procedure
Area of continuous movement of an explorer across the surface of the restoration
Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface
Measured: 6 months
Area of continuous movement of an explorer across the surface of the restoration
Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface
Measured: 12 months
Distance penetrated by the Explorer at the tooth restoration interface
The explorer will be drawn across the surface of the restoration toward the tooth
Measured: Immediately after procedure
Distance penetrated by the Explorer at the tooth restoration interface
The explorer will be drawn across the surface of the restoration toward the tooth
Measured: 6 months
Distance penetrated by the Explorer at the tooth restoration interface
The explorer will be drawn across the surface of the restoration toward the tooth
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start22 Oct 2020
- Primary completion18 Apr 2022
- Study completion28 Apr 2023
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.
- More trials run by Cairo 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Esmeail Hussien, Cairo University
- Investigators
- Esraa Es Hussien, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518371
- Sponsor's protocol ID
- CairoU-EEHussien
- Status last verified
- Aug 2023
- First submitted
- 12 Aug 2020
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance and Wear Resistance of Milled Resin Composite Material Versus Direct Nanohybrid Bulk-Fill Resin Composite in Restoration of Endodontically Treated Posterior Teeth Over One Year: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04518371
- Acronym / sponsor ID
- CairoU-EEHussien
- Conditions
- Endodontically Treated Teeth
- Keywords
- Endodontically Treated Teeth, Milled Composite, Clinical Performance, Occlusal Wear, IntraOral Scanner
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 18 Apr 2022 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 19 Aug 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.
In patients with endodontically treated teeth, will the Indirect Milled composite Endo-crown restorations have a better clinical performance and more wear resistance than the Direct Bulk-Fill resin composite restorations over one year?
Primary Objective: To evaluate clinical performance of different Techniques of Composite Restorations (Indirect restorations using a CAD/CAM grinding process, BRILLIANT Crios, Coltène/Whaledent AG, Switzerland or Direct a light-cured, bulk-fill nanocomposite restorative material, Filtek™ One Bulk Fill Restorative, 3M ESPE Dental Products, USA) in Endodontically treated posterior teeth.
Detailed description
The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University; The operator in charge will be Esraa Esmeail Hussien.
Null-hypothesis: There are no differences in the clinical performance of indirect CAD/CAM milled composite when compared to direct bulk-fil composite endocrowns when in the posterior area.
Aim: This clinical trial will be conducted to assess the clinical performance of using indirect Milled composite or direct bulk-fill resin composite Endo-crowns for restoring the endo-treated teeth, as well to measure the amount of wear on the occlusal tables of both restorations using Digital Scanner.
Patients will be selected from the outpatient clinic of the department Conservative Dentistry Department, Faculty of Dentistry, Cairo University
Clinical Steps:
- A tapered stone with rounded end in a high-speed handpiece with air /water coolant will be used to properly prepare the cavity walls to receive the indirect restoration and any remaining carious dentin will be excavated and removed.
- Cuspal tipping will be done by a wheel stone about 1.5-2mm.
- The entrance to the pulpal canal will be opened. Gutta percha will be removed to a depth not exceeding 2 mm to take advantage of the saddle-like anatomy of the cavity floor. This should be done with a nonabrasive instrument to maintain the integrity of the canal's entrance. No drilling into the dentin will be carried out.
- Any remaining undercuts will be blocked with conventional resin composite.
- The impression will be taken, and the final restoration will be fabricated either direct or indirect.
- The final restoration should be checked intraorally for proximal contacts, occlusion and marginal fit before cementation.
- Isolation of operatory field using rubber dam.
- Selective enamel etching technique will be applied for bonding of tooth structure, 35-40% phosphoric acid gel will be applied to the enamel margins only for 15 seconds, rinsed for 15 seconds and gently dried by cotton pellet.
- Adhesive will be used according to the manufacturers' instructions.
- Adhesive resin cement will be applied into the preparation. The restoration will be placed in the cavity and checked for complete seating. The cement will be light cured for only 2 seconds to facilitate removal of the excess. Then light curing will be done from all directions each for 40 seconds for achieving the final set.
- The proximal contacts will be checked with dental floss.
- The occlusion will be adjusted using articulating paper.
- Finishing and Polishing using finishing stones and polishing rubber points.
Primary Objective: To evaluate clinical performance of different Techniques of Composite Restorations (Indirect restorations using a CAD/CAM grinding process, BRILLIANT Crios, Coltène/Whaledent AG, Switzerland or Direct a light-cured, bulk-fill nanocomposite restorative material, Filtek™ One Bulk Fill Restorative, 3M ESPE Dental Products, USA) in Endodontically treated posterior teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indirect Restoration | Experimental | Other: Reinforced composite for the fabrication of permanent, indirect restorations using a CAD/CAM grinding process.Milled Resin Composite Block, Shock-absorbing effect due to the dentine-like modulus of elasticity makes BRILLIANT Crios extremely well suited for implant restorations.it is composed of dental glass (barium glass ˂ 1.0 μm), amorphous silica (Sio2 ˂ 20 nm), resin matrix (cross-linked methacrylates) and pigments (inorganic pigments such as ferrous oxide or titanium dioxide). |
| Direct Restoration | Active comparator | Other: Reinforced composite for the fabrication of permanent, indirect restorations using a CAD/CAM grinding process.3M™ Filtek™ One Bulk Fill Restorative is a visible light activated, restorative composite optimized to create fast and easy restorations. It is composed of fillers which are a combination of a non-agglomerated/non-aggregated 20 nm silica filler, 4 to 11 nm zirconia filler, zirconia/silica cluster filler and ytterbium trifluoride filler consisting of 100nm particles. The inorganic filler loading is about 76.5% by weight (58.5% by volume). |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Patients with asymptomatic endodontically treated molars.
- Males or Females.
- Good oral hygiene.
- Co-operative patients approving to participate in the study.
- Asymptomatic endodontically treated upper or lower molars with
Key exclusion criteria (14 listed)
- High caries index with poor oral hygiene.
- Severe medical complications.
- Pregnancy.
- Allergic history concerning methacrylates Disabilities.
- Heavy smoking.
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 |
|---|---|---|
| Reinforced composite for the fabrication of permanent, indirect restorations using a CAD/CAM grinding process.Also: CAD/CAM Composite endo-crownShock-absorbing effect due to the dentine-like modulus of elasticity makes BRILLIANT Crios extremely well suited for implant restorations.it is composed of dental glass (barium glass ˂ 1.0 μm), amorphous silica (Sio2 ˂ 20 nm), resin matrix (cross-linked methacrylates) and pigments | Other | Direct Restoration, Indirect Restoration |
Primary outcome
Degree of Continuity between natural tooth structure and the restoration
Time frame: Immediately after procedure
Tactile sensation checking the anatomic form to show if there is no discontinuity, Slight discontinuity, or discontinuity and failure
Degree of Continuity between natural tooth structure and the restoration
Time frame: 6 months
Tactile sensation checking the anatomic form to show if there is no discontinuity, Slight discontinuity, or discontinuity and failure
Degree of Continuity between natural tooth structure and the restoration
Time frame: 12 months
Tactile sensation checking the anatomic form to show if there is no discontinuity, Slight discontinuity, or discontinuity and failure
15 secondary outcomes
The degree of mismatch from the normal range of tooth shades and translucency
Time frame: Immediately after procedure
The degree of mismatch from the normal range of tooth shades and translucency
Time frame: 6 months
The degree of mismatch from the normal range of tooth shades and translucency
Time frame: 12 months
Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
Time frame: Immediately after procedure
Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
Time frame: 6 months
Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
Time frame: 12 months
Pain due to dentin hypersensitivity (evaporative stimulus)
Time frame: Immediately after procedure
Pain due to dentin hypersensitivity (evaporative stimulus)
Time frame: 6 months
Pain due to dentin hypersensitivity (evaporative stimulus)
Time frame: 12 months
Area of continuous movement of an explorer across the surface of the restoration
Time frame: Immediately after procedure
Area of continuous movement of an explorer across the surface of the restoration
Time frame: 6 months
Area of continuous movement of an explorer across the surface of the restoration
Time frame: 12 months
Distance penetrated by the Explorer at the tooth restoration interface
Time frame: Immediately after procedure
Distance penetrated by the Explorer at the tooth restoration interface
Time frame: 6 months
Distance penetrated by the Explorer at the tooth restoration interface
Time frame: 12 months
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 23 Aug 2023.
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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.
Esraa Es Hussien principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reinforced composite for the fabrication of permanent, indirect restorations using a CAD/CAM grinding process. in people with Endodontically Treated Teeth, run by Cairo 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 8 inclusion and 14 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 23 Aug 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. 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?
Degree of Continuity between natural tooth structure and the restoration (time frame: Immediately after procedure). The study lists 3 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 23 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.