Endodontically Treated TeethNCT05476419
Apical Gap Length and Adaptation of Zirconia Post Using Intraoral and Extraoral Scan of Silicon Impression Technique
A study testing Direct intra-oral scanning technique for the post space. in people with Endodontically Treated Teeth, run by Cairo University.
Trial summary
First, participants will undergo clinical and radiographic examination for taking all the needed preoperative records, then endodontically treated teeth preparation starting with removal of any carious or undermined tooth structure then ferrule preparation then followed by intra-radicular preparation and then… Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontically Treated Teeth
- What is being tested?
- Direct intra-oral scanning technique for the post space.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Dec 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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 16-65 years with endodontically treated anterior tooth or teeth \& in need of custom made post and core restoration.
- Be physically and psychologically able to tolerate conventional restorative procedures.
- Subject tooth free of clinical symptoms \& No requirement for endodontic retreatment expressed by the presence of periapical radiolucency around an endodontically treated tooth.
- Adequate level of oral hygiene expressed by the absence of signs of periodontal inflammation, bleeding on probing and periodontal pocket depth <4 mm.
- Capable of signing an informed consent
Who cannot join
- Advanced periodontitis affecting the mobility of the teeth (mobility grade II or higher)
- Pregnant or lactating females. 3. Patients with Psychiatric problems or unrealistic expectations.
- 4- Patients with endodontically treated teeth which is not functioning or showing any signs or symptoms that need endodontic retreatment.
- 5- Occlusion problems. 6- Absence of posterior stopper.
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Apical Gap Length and Adaptation of Custom Made Zirconia Post Using Digital Intraoral and Extraoral Scan of Conventional Silicon Impression Technique. (Randomized Controlled Clinical Trial)
First, participants will undergo clinical and radiographic examination for taking all the needed preoperative records, then endodontically treated teeth preparation starting with removal of any carious or undermined tooth structure then ferrule preparation then followed by intra-radicular preparation and then placement of the provisional restoration. In the third visit we will take the final impression of the post space for each patient by using the intraoral scan and extraoral scan o f the conventional impression. Then assessment of the apical gap length by using digital periapical radiograph using the paralleling technique and assessment of post adaptation using replica technique followed by placement and permanent cementation of the zirconia custom made post and core restoration that showed less apical gap length and better adaptation then taking the final impression for the extracoronal restoration and finally permanent cementation of the extra coronal fixed restoration.
Read the detailed description
Examination and diagnosis:Selection and examination of the patients according to inclusion and exclusion criteria. Diagnosis of the patient's chief complaint and teeth that will be involved in this study will be done.
Primary impression will be taken to produce study cast. The patients will be asked to maintain good oral hygiene measures by using tooth brush twice daily.
Taking a professional pre-operative photo.
Tooth preparation procedure:
- Removal of any carious or undermined tooth structure then coronal preparation will be done with a ferrule of at least 1.5 to 2 mm then followed by root canal preparation to an adequate length and diameter.
- After tooth preparation, the final impression will be taken for the post space for each participant by using the intraoral scan and extraoral scan of the conventional silicone impression.
- Fabrication of temporary restoration using composite resin temporary material and cemented using Zinc Oxide eugenol free temporary cement.
Fabrication of restoration:
Monolithic zirconia will be used for the fabrication of post and core restoration.
Assessment of the apical gap length by using digital periapical radiograph using the paralleling technique. Assessment of post adaptation using replica technique followed by placement and permanent cementation of the zirconia custom made post and core restoration that showed less apical gap length and better adaptation. Taking the final impression for the extracoronal restoration. Finally permanent cementation of the extra coronal fixed restoration.
- Conditions
- Endodontically Treated Teeth
- Being tested
- Direct intra-oral scanning technique for the post space.
- 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 intra-oral scanning technique for the post space.Other
scanning of prepared dental post space directly inside the patient mouth by using an intra-oral scanner
| Study group | Role | What they receive |
|---|---|---|
| Direct intra-oral scanning technique for the post space. | Experimental | intervention will be the direct scanning of the prepared post space inside the patient mouth by using an intraoral scanner. Receives: Other: Direct intra-oral scanning technique for the post space. |
| In-direct scanning of the conventional post space silicone impression. | Active comparator | The comparator will be extraoral scanning of the conventional sillicon impression of the prepared post space by using an extraoral scanner. Receives: Other: Direct intra-oral scanning technique for the post space. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apical gap length
measuring apical gap length by the digital Periapical radiograph using the paralleling technique.
Measured: through study completion, an average of 1 year".
Secondary outcomes (1)
Post adaptation
Measuring post adaptation by using Replica technique
Measured: through study completion, an average of 1 year".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study startSep 2023 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionDec 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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rivan Mahmoud Gamal Mohamed El-boghdady, Cairo University
- Investigators
- Rv Ma El-boghdady, Ass lecturer, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476419
- Sponsor's protocol ID
- Theme 3 (FPD3-3-8)RM
- Status last verified
- Feb 2023
- First submitted
- 23 Jul 2022
- Last updated
- 9 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Apical Gap Length and Adaptation of Custom Made Zirconia Post Using Digital Intraoral and Extraoral Scan of Conventional Silicon Impression Technique. (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT05476419
- Acronym / sponsor ID
- Theme 3 (FPD3-3-8)RM
- Conditions
- Endodontically Treated Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Jul 2022 (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.
First, participants will undergo clinical and radiographic examination for taking all the needed preoperative records, then endodontically treated teeth preparation starting with removal of any carious or undermined tooth structure then ferrule preparation then followed by intra-radicular preparation and then placement of the provisional restoration. In the third visit we will take the final impression of the post space for each patient by using the intraoral scan and extraoral scan o f the conventional impression. Then assessment of the apical gap length by using digital periapical radiograph using the paralleling technique and assessment of post adaptation using replica technique followed by placement and permanent cementation of the zirconia custom made post and core restoration that showed less apical gap length and better adaptation then taking the final impression for the extracoronal restoration and finally permanent cementation of the extra coronal fixed restoration.
Detailed description
Examination and diagnosis:Selection and examination of the patients according to inclusion and exclusion criteria. Diagnosis of the patient's chief complaint and teeth that will be involved in this study will be done.
Primary impression will be taken to produce study cast. The patients will be asked to maintain good oral hygiene measures by using tooth brush twice daily.
Taking a professional pre-operative photo.
Tooth preparation procedure:
- Removal of any carious or undermined tooth structure then coronal preparation will be done with a ferrule of at least 1.5 to 2 mm then followed by root canal preparation to an adequate length and diameter.
- After tooth preparation, the final impression will be taken for the post space for each participant by using the intraoral scan and extraoral scan of the conventional silicone impression.
- Fabrication of temporary restoration using composite resin temporary material and cemented using Zinc Oxide eugenol free temporary cement.
Fabrication of restoration:
Monolithic zirconia will be used for the fabrication of post and core restoration.
Assessment of the apical gap length by using digital periapical radiograph using the paralleling technique. Assessment of post adaptation using replica technique followed by placement and permanent cementation of the zirconia custom made post and core restoration that showed less apical gap length and better adaptation. Taking the final impression for the extracoronal restoration. Finally permanent cementation of the extra coronal fixed restoration.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct intra-oral scanning technique for the post space. | Experimental | Other: Direct intra-oral scanning technique for the post space.intervention will be the direct scanning of the prepared post space inside the patient mouth by using an intraoral scanner. |
| In-direct scanning of the conventional post space silicone impression. | Active comparator | Other: Direct intra-oral scanning technique for the post space.The comparator will be extraoral scanning of the conventional sillicon impression of the prepared post space by using an extraoral scanner. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age 16-65 years with endodontically treated anterior tooth or teeth \& in need of custom made post and core restoration.
- Be physically and psychologically able to tolerate conventional restorative procedures.
- Subject tooth free of clinical symptoms \& No requirement for endodontic retreatment expressed by the presence of periapical radiolucency around an endodontically treated tooth.
- Adequate level of oral hygiene expressed by the absence of signs of periodontal inflammation, bleeding on probing and periodontal pocket depth <4 mm.
- Capable of signing an informed consent
Key exclusion criteria (5 listed)
- Advanced periodontitis affecting the mobility of the teeth (mobility grade II or higher)
- Pregnant or lactating females. 3. Patients with Psychiatric problems or unrealistic expectations.
- 4- Patients with endodontically treated teeth which is not functioning or showing any signs or symptoms that need endodontic retreatment.
- 5- Occlusion problems. 6- Absence of posterior stopper.
- -
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 intra-oral scanning technique for the post space.scanning of prepared dental post space directly inside the patient mouth by using an intra-oral scanner | Other | Direct intra-oral scanning technique for the post space., In-direct scanning of the conventional post space silicone impression. |
Primary outcome
Apical gap length
Time frame: through study completion, an average of 1 year".
measuring apical gap length by the digital Periapical radiograph using the paralleling technique.
1 secondary outcome
Post adaptation
Time frame: through study completion, an average of 1 year".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Rv Ma El-boghdady, Ass lecturer principal investigator
Questions about this trial
What is this clinical trial studying?
A study testing Direct intra-oral scanning technique for the post space. in people with Endodontically Treated Teeth, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Rv Mh El-boghdady, Ass lecturer (01007172887, rivan.elboghdady@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apical gap length (time frame: through study completion, an average of 1 year".). 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 9 Feb 2023.