Endodontically Treated TeethNCT04561167
Clinical Performance of the Indirect Resin Composite Restorations in Endodontically Treated Teeth
A study testing Cuspal reduction in MOD cavity in endodontically treated teeth and No cuspal reduction in MOD cavity in endodontically treated teeth in people with Endodontically Treated Teeth, run by Cairo University at 1 site in Egypt.
Trial summary
Does the cuspal reduction during cavity preparation for indirect resin composite restorations in endodontically treated teeth increase the clinical performance when compared to cavities prepared without cuspal reduction? Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontically Treated Teeth
- What is being tested?
- Cuspal reduction in MOD cavity in endodontically treated teeth and No cuspal reduction in MOD cavity in endodontically treated teeth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 1 Oct 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Only co-operative patients approving to participate in the trial.
- Good oral hygiene.
- Medically free adult patients.
- The age range of the patients is 13-18 years
- Patients havind Endodontically treated molars with remaining two walls.
- Teeth with no periapical lesion or radiolucency.
Show all 11Show fewer
- Root canal treatment finished from maximum two weeks with no clinical symptoms.
- Prepared cavity with no undermined enamel walls.
- The thickness of the remaining walls not less than 2 mm.
- Functioning tooth with presence of an opposing.
- Healthy periodontium
Who cannot join
- Old age patients.
- Patients with disabilities.
- Patients having systemic diseases or severe medically compromised.
- Patients with of severe bruxism, clenching or temporomandibular joint disorders.
- Poor oral hygiene.
- Teeth with severe dilacerations.
Show all 15Show fewer
- Teeth with periapical lesions.
- Teeth with visible cracks.
- Teeth with internal or external root resorption.
- Teeth with calcified root canals.
- Teeth with mobility.
- Teeth with undermined enamel walls.
- Non-functioning tooth with no opposing tooth.
- Heavy occlusion or signs of severe attrition.
- Severe periodontal affection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance of the Indirect Resin Composite Restorations in Endodontically Treated Teeth With Different Cavity Preparation Designs: (A Randomized Clinical Trial)
Does the cuspal reduction during cavity preparation for indirect resin composite restorations in endodontically treated teeth increase the clinical performance when compared to cavities prepared without cuspal reduction?
Read the detailed description
Selection and examination of the all patients will be done according to inclusion and exclusion criteria( by Hoda omar fouda in the Faculty of Dentistry Cairo University, Egypt ) from the outpatient clinic of the conservative department of the faculty of oral and dental medicine , cairo university .Patients should have an endodontically treated molar with remaining three walls fulfilling the inclusion criteria of the selected teeth or patients who need root canal treatment to be done prior to restoration to be enrolled in the study. Root canal treatment for all patients will be done by step back technique using rotary files .Sodium hypochlorite and EDTA solution will be used as root canal irrigant solution. Root canals will be obturated with gutta percha cones using AH Plus (Dentsply, Konstanz Germany). Eugenol based sealers will avoided to avoid the contamination of the remaining walls with eugenol that can interfere with the polymerization of the adhesive.
Eugenol free temporary filling material (Coltosol F by Coltene, Switzerland) will be used to seal the cavity till the restorative visit A digital periapical radiograph will be done to check the quality of the root canal treatment. The selected tooth should be free from any periapical radiolucency, missed canals or poor obturation. The periodontal condition of the tooth will be also checked radiographically. The tooth should be free from any clinical symptoms as pain on biting or swelling. A period not more than a month should pass from the root canal treatment to avoid any coronal leakage that might affect the prognosis of the root canal treatment during the time of the study. Any defects in the temporary filling material should be restored again to assure proper coronal seal till the beginning of the treatment. Before the removal of the temporary filling, assessment of centric and eccentric occlusal contacts will be performed with an articulating paper. The tooth should be then checked for the contact points in the centric relation and eccentric movements It is important to determine the contact points during the centric and eccentric movements to maintain the tooth restoration interface at a stress free areas as much as possible for more durable bonding. The quadrant with the cavity will be isolated using rubber dam system with two suctions tips one below the rubber dam sheet and the other one near to the tooth to keep the working area always clean and keep the patient comfortable during the procedures. Using straight and round blue coded diamond stones attached to high speed handpiece with copious air and water coolant, the temporary filling will be removed from the cavity. The cavity should then be checked for any remaining carious lesions to be removed. All the undermined enamel walls should be removed so that all the remaining cavity walls have well supported sound enamel margins. Any soft carious lesions will be by a sharp spoon excavator. Any gutta-percha remnants in the pulp chamber should be removed till the gutta percha becomes at the level of the orifice and all the walls and floor are completely clean. All the procedures will be performed with magnifying loupes 3.5 x (Univet, Italy). The angulation of the cavity walls will be adjusted to be 6 degrees diverge of the axial inclination using blue coded diamond tapered with round end bur diameter 16, length 10.
Standardization of the prepared cavity dimensions should be done as follows:
- For the inlay group thickness of remaining walls (in order to maintain them) has to be 1.5 mm.
- The occlusal inter-cuspal distance ranges from 4-5 mm
4- Width of occlusal isthmus had to be 2-3 mm. 5- Buccal and lingual walls of the proximal parts of the cavity will be prepared using the same diamond bur (MIDWEST Dentsply) used for the occlusal part of the cavity to provide the same angle of divergence (6 degrees) as that of the occlusal walls. 6- The proximal boxes corresponds to one-third the distance between the buccal and lingual surfaces of the teeth 7- The gingival floor of the proximal part of the cavity has to be continuous with the pulpal floor of the occlusal part having the same depth. 8- Interproximal overjet has to be ≤ 2 mm. 9- The internal line angles should be rounded, the cavo-surface angles should be 90° For the Intervention Group: no cuspal reduction will be done as these will be the cavities prepared to receive the inlay restorations For the Comparator Group: cuspal reduction to buccal and lingual cusps will be done as these will be the cavities prepared to receive the onlay restorations
Acid etching:
Selective etching technique using a 35% phosphoric acid gel (Scotchbond™ Universal Etchant 3M) on the marginal enamel for 15 seconds. The gel will then thoroughly rinsed for about 30 seconds using air water spray and then air dried for 5 seconds.
Application of adhesive:
After proper dryness and with the aid of a micro-brush (Microbrush International, USA), the Prime and Bond universal adhesive (Dentsply Sirona) will be applied over all the cavity surfaces according to the manufacturer's instructions and rubbed for 20 seconds then blown with a gentle air blow for 5 seconds to evaporate the solvent and then light cured for 10 seconds using LED curing light (Elipar S10, 3M ESPE) at a light intensity of 1200 mw/cm2.
Application of the base:
Bulk fill flowable composite SDR (Dentsply sirona) of universal shade will be directly applied to the floor of the cavity to fill the pulp chamber from bottom to top and light cured for 10 seconds according to the manufacturer's instructions with the same light curing device as the adhesive.
Milling of the designed restoration:
The operator will adhere strictly to the manufacturer's instructions in the imaging, computer design and machining of the restorations. A CEREC Primescan unit with Operating System 1.21 and the extended machining option for the milling process. BRILLIANT Crios Composite Blocks for CEREC® will be used to design and mill the inlays and onlays.
Cementation protocol:
The fitting surface of the restoration will be treated as follows to be ready for cementation:
- Sandblasting by AquaCare Air Abrasion Unit using aluminum oxide particles of 0.5 mm particle size.
- Ultrasonic cleaning using InvisiClean ultrasonic cleaner for one minute.
- Prime and bond universal adhesive layer will be applied, air thinned for 5 seconds and cured for 10 seconds The RelyX Unicem clicker 3M ESPE will be used for the restoration cementation and final finishing and polishing will be done if any occlusal adjustments are done to the restoration
- Conditions
- Endodontically Treated Teeth
- Being tested
- Cuspal reduction in MOD cavity in endodontically treated teeth, No cuspal reduction in MOD cavity in endodontically treated teeth
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cuspal reduction in MOD cavity in endodontically treated teethOther
Not only the quality of endodontic treatment that affects the prognosis of the endodontically treated tooth, but the subsequent restorative treatment as well. Coverage, Endocrowns, Onlays, Inlays Restorations on Fracture Resistance of Endodontically Treated Molars, it was found that the worst results came to the inlay restorations and this was attributed to geometric form of preparation that exert a wedging force acting to split the tooth when under occlual stress however, onlay and full coverage direct the force along the long axis by overlaying the cusp tips and a portion of buccal and lingual surface thus opposing the wedging action created by internal design of restoration (Magne P and Belser C. et al 2003) That's why, choosing such a design as a comparator to the design of the cuspal reduction and further coverage (onlay) is crucial to show the importance of cuspal coverage for the indirect resin composite restoration in the endodontically treated teeth.
No cuspal reduction in MOD cavity in endodontically treated teethOther
In an invitro study done by (Ahmed Hamdy 2015) investigating the effect of Full The amount of lost internal tooth structure as well as the coronal hard tissue in an endodontically treated tooth is considered the main factors that make the tooth susceptible to biomechanical failure when compared to a vital tooth. (Guo J et al 2016) .
| Study group | Role | What they receive |
|---|---|---|
| Cuspal reduction in MOD Cavity in endodontically treated teeth | Experimental | Cavity design is of prime importance for the restoration of endodontically treated teeth. The cavity design plays an important role in the protection of the remaining tooth structure as well as the restoration. Cuspal reducuction and further coverage by the CAD/CAM generated indirect resin composite restoration has been proved in literature by the retrospective study done by (Chrepa V et al 2014) which studied 189 posterior endodontically treated teeth receiving indirect composite onlays with a median follow up time of 37 months and suggested this type of restoration as a viable option with 100% tooth survival and 96.8% restoration survival. Receives: Other: Cuspal reduction in MOD cavity in endodontically treated teeth |
| No cuspal reduction in endodontically treated teeth | Active comparator | In the present study, choosing the comparator to be the cavity design without cuspal reduction and further coverage (inlay) is done as an attempt to reduce the application of inlays in endodontically treated teeth. In accordance to the in-vitro study done by (M. D. Al Amri et al 2016) which tested the fracture resistance of endodontically treated mandibular first molars with conservative access cavity and different restorative techniques, catastrophic failures were highest in the composite group (100%), followed by the inlay and the amalgam groups (91.67%) and this was referred to the adhesive bonding mechanism of the composite restoration and the wedging effect of the inlay and the amalgam restorations (Rivera EM andWalton RE 2015) Receives: Other: No cuspal reduction in MOD cavity in endodontically treated teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal adaptation
Visual inspection with explorer and mirror by measuring the 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
Secondary outcomes (7)
Fracture of tooth and /or restoration
Visual inspection with explorer and mirror, to find the amount of fracture either in tooth or restoration
Measured: 12 months
Anatomic Form
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
Surface texture
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
post operative sensitivity
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
Retention
Visual inspection by the explorer and mirror to find out if there is loss of the restoration or no loss of the restoration
Measured: 12 months
Color Match
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
Secondary Caries
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Oct 2020
- Primary completion1 Oct 2023
- Study completion1 Oct 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hoda omar tawfeek hussien fouda, Cairo University
- Investigators
- Hoda Fouda, master, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561167
- Sponsor's protocol ID
- Egameel43
- Status last verified
- Jan 2024
- First submitted
- 13 Sep 2020
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Undecided: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of the Indirect Resin Composite Restorations in Endodontically Treated Teeth With Different Cavity Preparation Designs: (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04561167
- Acronym / sponsor ID
- Egameel43
- Conditions
- Endodontically Treated Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 23 Sep 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.
Does the cuspal reduction during cavity preparation for indirect resin composite restorations in endodontically treated teeth increase the clinical performance when compared to cavities prepared without cuspal reduction?
Detailed description
Selection and examination of the all patients will be done according to inclusion and exclusion criteria( by Hoda omar fouda in the Faculty of Dentistry Cairo University, Egypt ) from the outpatient clinic of the conservative department of the faculty of oral and dental medicine , cairo university .Patients should have an endodontically treated molar with remaining three walls fulfilling the inclusion criteria of the selected teeth or patients who need root canal treatment to be done prior to restoration to be enrolled in the study. Root canal treatment for all patients will be done by step back technique using rotary files .Sodium hypochlorite and EDTA solution will be used as root canal irrigant solution. Root canals will be obturated with gutta percha cones using AH Plus (Dentsply, Konstanz Germany). Eugenol based sealers will avoided to avoid the contamination of the remaining walls with eugenol that can interfere with the polymerization of the adhesive.
Eugenol free temporary filling material (Coltosol F by Coltene, Switzerland) will be used to seal the cavity till the restorative visit A digital periapical radiograph will be done to check the quality of the root canal treatment. The selected tooth should be free from any periapical radiolucency, missed canals or poor obturation. The periodontal condition of the tooth will be also checked radiographically. The tooth should be free from any clinical symptoms as pain on biting or swelling. A period not more than a month should pass from the root canal treatment to avoid any coronal leakage that might affect the prognosis of the root canal treatment during the time of the study. Any defects in the temporary filling material should be restored again to assure proper coronal seal till the beginning of the treatment. Before the removal of the temporary filling, assessment of centric and eccentric occlusal contacts will be performed with an articulating paper. The tooth should be then checked for the contact points in the centric relation and eccentric movements It is important to determine the contact points during the centric and eccentric movements to maintain the tooth restoration interface at a stress free areas as much as possible for more durable bonding. The quadrant with the cavity will be isolated using rubber dam system with two suctions tips one below the rubber dam sheet and the other one near to the tooth to keep the working area always clean and keep the patient comfortable during the procedures. Using straight and round blue coded diamond stones attached to high speed handpiece with copious air and water coolant, the temporary filling will be removed from the cavity. The cavity should then be checked for any remaining carious lesions to be removed. All the undermined enamel walls should be removed so that all the remaining cavity walls have well supported sound enamel margins. Any soft carious lesions will be by a sharp spoon excavator. Any gutta-percha remnants in the pulp chamber should be removed till the gutta percha becomes at the level of the orifice and all the walls and floor are completely clean. All the procedures will be performed with magnifying loupes 3.5 x (Univet, Italy). The angulation of the cavity walls will be adjusted to be 6 degrees diverge of the axial inclination using blue coded diamond tapered with round end bur diameter 16, length 10.
Standardization of the prepared cavity dimensions should be done as follows:
- For the inlay group thickness of remaining walls (in order to maintain them) has to be 1.5 mm.
- The occlusal inter-cuspal distance ranges from 4-5 mm
4- Width of occlusal isthmus had to be 2-3 mm. 5- Buccal and lingual walls of the proximal parts of the cavity will be prepared using the same diamond bur (MIDWEST Dentsply) used for the occlusal part of the cavity to provide the same angle of divergence (6 degrees) as that of the occlusal walls. 6- The proximal boxes corresponds to one-third the distance between the buccal and lingual surfaces of the teeth 7- The gingival floor of the proximal part of the cavity has to be continuous with the pulpal floor of the occlusal part having the same depth. 8- Interproximal overjet has to be ≤ 2 mm. 9- The internal line angles should be rounded, the cavo-surface angles should be 90° For the Intervention Group: no cuspal reduction will be done as these will be the cavities prepared to receive the inlay restorations For the Comparator Group: cuspal reduction to buccal and lingual cusps will be done as these will be the cavities prepared to receive the onlay restorations
Acid etching:
Selective etching technique using a 35% phosphoric acid gel (Scotchbond™ Universal Etchant 3M) on the marginal enamel for 15 seconds. The gel will then thoroughly rinsed for about 30 seconds using air water spray and then air dried for 5 seconds.
Application of adhesive:
After proper dryness and with the aid of a micro-brush (Microbrush International, USA), the Prime and Bond universal adhesive (Dentsply Sirona) will be applied over all the cavity surfaces according to the manufacturer's instructions and rubbed for 20 seconds then blown with a gentle air blow for 5 seconds to evaporate the solvent and then light cured for 10 seconds using LED curing light (Elipar S10, 3M ESPE) at a light intensity of 1200 mw/cm2.
Application of the base:
Bulk fill flowable composite SDR (Dentsply sirona) of universal shade will be directly applied to the floor of the cavity to fill the pulp chamber from bottom to top and light cured for 10 seconds according to the manufacturer's instructions with the same light curing device as the adhesive.
Milling of the designed restoration:
The operator will adhere strictly to the manufacturer's instructions in the imaging, computer design and machining of the restorations. A CEREC Primescan unit with Operating System 1.21 and the extended machining option for the milling process. BRILLIANT Crios Composite Blocks for CEREC® will be used to design and mill the inlays and onlays.
Cementation protocol:
The fitting surface of the restoration will be treated as follows to be ready for cementation:
- Sandblasting by AquaCare Air Abrasion Unit using aluminum oxide particles of 0.5 mm particle size.
- Ultrasonic cleaning using InvisiClean ultrasonic cleaner for one minute.
- Prime and bond universal adhesive layer will be applied, air thinned for 5 seconds and cured for 10 seconds The RelyX Unicem clicker 3M ESPE will be used for the restoration cementation and final finishing and polishing will be done if any occlusal adjustments are done to the restoration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cuspal reduction in MOD Cavity in endodontically treated teeth | Experimental | Other: Cuspal reduction in MOD cavity in endodontically treated teethCavity design is of prime importance for the restoration of endodontically treated teeth. The cavity design plays an important role in the protection of the remaining tooth structure as well as the restoration. Cuspal reducuction and further coverage by the CAD/CAM generated indirect resin composite restoration has been proved in literature by the retrospective study done by (Chrepa V et al 2014) which studied 189 posterior endodontically treated teeth receiving indirect composite onlays with a median follow up time of 37 months and suggested this type of restoration as a viable option with 100% tooth survival and 96.8% restoration survival. |
| No cuspal reduction in endodontically treated teeth | Active comparator | Other: No cuspal reduction in MOD cavity in endodontically treated teethIn the present study, choosing the comparator to be the cavity design without cuspal reduction and further coverage (inlay) is done as an attempt to reduce the application of inlays in endodontically treated teeth. In accordance to the in-vitro study done by (M. D. Al Amri et al 2016) which tested the fracture resistance of endodontically treated mandibular first molars with conservative access cavity and different restorative techniques, catastrophic failures were highest in the composite group (100%), followed by the inlay and the amalgam groups (91.67%) and this was referred to the adhesive bonding mechanism of the composite restoration and the wedging effect of the inlay and the amalgam restorations (Rivera EM andWalton RE 2015) |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Only co-operative patients approving to participate in the trial.
- Good oral hygiene.
- Medically free adult patients.
- The age range of the patients is 13-18 years
- Patients havind Endodontically treated molars with remaining two walls.
Key exclusion criteria (15 listed)
- Old age patients.
- Patients with disabilities.
- Patients having systemic diseases or severe medically compromised.
- Patients with of severe bruxism, clenching or temporomandibular joint disorders.
- Poor oral hygiene.
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 |
|---|---|---|
| Cuspal reduction in MOD cavity in endodontically treated teethNot only the quality of endodontic treatment that affects the prognosis of the endodontically treated tooth, but the subsequent restorative treatment as well. Coverage, Endocrowns, Onlays, Inlays Restorations on Fracture Resistance of Endodontically Treated Molars, it was found that the worst results came to the inlay restorations and this was attributed to geometric form of preparation that exert a wedging force acting to split the tooth when under occlual stress however, onlay and full coverage direct the force along the long axis by overlaying the cusp tips and a portion of buccal and lingual surface thus opposing the wedging action created by internal design of restoration (Magne P and Belser C. et al 2003) That's why, choosing such a design as a comparator to the design of the cuspal reduction and further coverage (onlay) is crucial to show the importance of cuspal coverage for the indirect resin composite restoration in the endodontically treated teeth. | Other | Cuspal reduction in MOD Cavity in endodontically treated teeth |
| No cuspal reduction in MOD cavity in endodontically treated teethIn an invitro study done by (Ahmed Hamdy 2015) investigating the effect of Full The amount of lost internal tooth structure as well as the coronal hard tissue in an endodontically treated tooth is considered the main factors that make the tooth susceptible to biomechanical failure when compared to a vital tooth. (Guo J et al 2016) . | Other | No cuspal reduction in endodontically treated teeth |
Primary outcome
Marginal adaptation
Time frame: 12 months
Visual inspection with explorer and mirror by measuring the distance penetrated by the explorer at the tooth restoration interface. The explorer will be drawn across the surface of the restoration toward the tooth
7 secondary outcomes
Fracture of tooth and /or restoration
Time frame: 12 months
Anatomic Form
Time frame: 12 months
Surface texture
Time frame: 12 months
post operative sensitivity
Time frame: 12 months
Retention
Time frame: 12 months
Color Match
Time frame: 12 months
Secondary Caries
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 11 Jan 2024.
- Individual participant dataSharing planned: Yes. Undecided: It is not yet known if there will be a plan to make IPD available.
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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 Fouda, master 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 Cuspal reduction in MOD cavity in endodontically treated teeth and No cuspal reduction in MOD cavity in endodontically treated teeth 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 11 inclusion and 15 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 11 Jan 2024. 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?
Marginal adaptation (time frame: 12 months). 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 11 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.