Cementation Teeth; HyperplasiaNCT05875688
Cementation Techniques; an In-vitro Study
A study testing Cementation Technique A, Cementation Technique B and Cementation Technique C in people with Cementation Teeth; Hyperplasia and Dental Cements, run by Ziauddin University at 1 site in Pakistan.
Trial summary
The goal of this observational study invitro study was to compare the different cementation techniques used to lute full veneer crowns on extracted and prepared teeth using Glass Ionomer Cement type 1. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cementation Teeth; Hyperplasia, Dental Cements, Tooth Crown Fracture
- What is being tested?
- Cementation Technique A, Cementation Technique B and Cementation Technique C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Jan 2019to 6 Sep 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Second pre-molar tooth.
- Mandibular arch.
- Visibly sound tooth; without any pathology e.g. dental caries
- Extraction referred by Orthodontics Department.
Who cannot join
- Carious teeth.
- Fractured or broken teeth.
- Teeth with patient history of dental anomaly.
- Teeth with any restoration e.g. filling.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Cementation Techniques on Retention of Full Veneer Crowns; an In-vitro Study
The goal of this observational study invitro study was to compare the different cementation techniques used to lute full veneer crowns on extracted and prepared teeth using Glass Ionomer Cement type 1.
The main question[s] it aims to answer are:
Read more
The in-vitro effect cement application techniques on retention of full veneer crowns.
Which of the three different cementation techniques in-vitro provide a greater retention for a full veneer crown and will it achieve better retention using the concluded method for longer duration of cemented crown in oral cavity.
To use of adequate amount of cement to avoid wastage. The principal investigator applied the Glass ionomer cement in three different techniques on custom prepared crowns and with the help of an Universal Testing Machine debonded the crown from the prepared tooth. The results were compared amongst the three categories and the technique C, proved to be the superlative amongst the three.
Read the detailed description
- Tooth selection The procedure started by informing the oral surgery department to reserve mandibular premolar teeth that were being extracted each day, followed by taking patient consent for the purpose of research. The extracted teeth collected were kept in hydrogen peroxide for 5 minutes and then washed under tap water for any visible debris. The teeth were then stored in Formalin 10% for a period of 7-days, as per Centers for Disease Control and Prevention disinfection protocols. The teeth were then transported in Hanks Balanced Salt solution to maintain disinfection and tooth quality.
- Preparation of tooth mounts The extracted teeth were then mounted in an acrylic block using self-cure acrylic resin (Shofu self cure acrylic resin, Japan). 0.5 mL of liquid was dispensed into a mixing cup, then 1 g of powder was added and quickly mixed using a spatula for 10 - 15 sec. Preformed plastic cylinders (Height; 55mm, Diameter; 20mm) were used, and inner walls painted with petroleum jelly for easy removal. The extracted teeth were then inserted in these cylinders filled with acrylic dough. Following manufacturer's instructions, it was ensured that the entire procedure was completed within 2 minutes after mixing was finished and at room temperature. The moulds were then left for an hour at room temperature to ensure complete chemical curing.
- Crown preparation Following complete chemical cure the teeth were prepared using a high-speed handpiece with water irrigation with diamond bur (Head Diameter: 1.2mm, Head Length: 7.7mm, 06-125µmm). They were first reduced in occlusal anatomical planes and a chamfer finish line (approximately 0.75mm) was given all around. Total Occlusal Convergence was kept at 20◦ and 25◦ with a clinical height of 5mm. Preparation dimensions (Total Occlusal Convergence, height) of the teeth were checked using computer software (AutoCAD 2000) after taking pictures with digital single-lens reflex camera with 105mm lens at 100mm. The distance was reproduced using a standard metal scale. The tooth mounts were labelled and kept in Hank's Balanced Salt Solution to maintain tissue health. Any tooth that did not meet the preparation requirements was discarded according to the Centers for Disease Control and Prevention criteria. The data collection was performed by the principal investigator. Dental photograph measurements were initially performed by the supervisor. To avoid the photographic error the photographs were calibrated by measuring the prepared tooth and scaling it on the AutoCAD software. The complete photography setup was stationary during the data collection process. Then, the data between the two operators were subjected to correlation analysis, and a strong correlation value was found (0.839). Furthermore, 20% of photographs were then re- assessed after a period of 2 weeks by the same operator. The data was analyzed later by formula to confirm intra-operator reliability through correlation statistics. As proven earlier through studies by dental morphometric measurements done by 2D image analysis can be performed by multiple operators with an excellent reliability.
- Crown fabrication Wax-up for metal crowns was done with metal extension (25mm), to engage them in the Universal Testing Machine, using Dental Inlay casting wax (Inlay wax medium stick; GC-Dental Corp. Japan). The wax up was then invested using phosphate bonded gypsum material (GC-Super, Japan) and cast with Nickel-Chromium Ni-Cr metal alloy at the Prosthodontics laboratory of Fatima Jinnah Dental College. The cast crowns were then finished used metal finishing discs, making sure the metal extensions were not less than 20mm. The fitting surface of all crowns were sandblasted accordingly and were made ready for cementation process. The teeth were numbered between 1-120 for record purposes and random assignment to either of the study groups.
- Cementation Tooth mounts were randomized using their serial numbers, to either of the three cement application techniques. This random allocation was done by generating a random sequence using Microsoft Excel by one of the department's lecturers, not directly related to the study. 40 teeth were allocated to each group. This sequence was passed on to an external operator (a general dentist), again not related to the primary research team, who was trained by the PI prior to study commencement on how to apply cement according to the operational definitions of the three cementation techniques under observation in this study. The cementation process started with mixing of permanent glass ionomer type-I luting cement (3M Ketac Cem Radiopaque Hand mix, USA) according to the manufacturer's recommendation by a single operator to ensure uniformity of mixing technique. The liquid component of Glass Ionomer Cement was measured using a 1cc syringe, while powder was measured using manufacturer provided scoop to ensure equal amount of cement was mixed. The mixing was done on a glossy paper pad provided by the manufacturer. The external operator cemented the metal crowns on the tooth mounts according to their allocation of cementation category. They were then seated by applying 80Newton pressure using a hydraulic press for 10 minutes. After ensuring the cement had dried completely the cemented crowns (on mounts) were left for seven days, soaked in distilled water to ensure hydration and to replicate intra-oral moisture conditions.
- Testing for retention On the eighth day, the PI undertook the experiment of retention testing. To help in minimizing bias while performing the retention testing, the PI and field assistant did not know which cement application technique had been used under mounted tooth being observed. The two components (Tooth mount with cemented crown) were then attached to a Universal Testing Machine (INSTRON-4301) and tensile forces were applied to check the retention of the crown. The amount of force required was monitored on the computer. The force of traction was increased slowly till the crown de-bonded and came off the prepared tooth. That value of force in Newtons was noted in the proforma against the tooth mount's serial number. The entire procedure was done under supervision of a field assistant from Pakistan Council of Scientific and Industrial Research laboratory. PI was unblinded after completion of data analysis. The serial number allocation to study groups was directly conveyed to the statistician by the external observer. All data were recorded in pre-formed proforma.
- Being tested
- Cementation Technique A, Cementation Technique B, Cementation Technique C
- Keywords
- Cementation, Cementation techniques, Crowns, Glass-ionomer cement, Retention
- Medical subject headings
- Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cementation Technique AOther
- Use of adequate amount of cement.
- Prevention of wastage of cement.
- Retention of crowns for longer duration.
Cementation Technique BOther
- Use of Sufficient Cement Quantity.
- Keeping cement from going to waste.
- Increased time that crowns remain in place.
Cementation Technique COther
- The utilisation of an appropriate quantity of cement.
- The mitigation of cement waste.
- Prolonged retention of dental crowns.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Filling the crown with cement up to margins. Receives: Other: Cementation Technique A |
| Group B | Experimental | Applying a cement layer on all fitting surfaces. Receives: Other: Cementation Technique B |
| Group C | Experimental | Applying a cement layer on all fitting surfaces except occlusal surface. Receives: Other: Cementation Technique C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cementation technique A,B and C
- Filling the crown with cement up to margins.
- Applying a cement layer on all fitting surfaces.
- Applying a cement layer on all fitting surfaces except occlusal surface.
Each of the aforementioned groups exhibits distinct measures of tensile strength. Each group will be compared with one another in terms of the cementation technique used, specifically in relation to Newton force.
A questionnaire was not employed for comparative purposes among the three groups; instead, the unit of force (Newton) was utilized to compare each group.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start6 Jan 2019
- Primary completion6 Sep 2019
- Study completion6 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cementation Teeth; HyperplasiaStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziauddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875688
- Sponsor's protocol ID
- 3363809324
- Status last verified
- May 2023
- First submitted
- 16 Jan 2023
- Last updated
- 25 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cementation Techniques on Retention of Full Veneer Crowns; an In-vitro Study
- ClinicalTrials.gov ID
- NCT05875688
- Acronym / sponsor ID
- 3363809324
- Keywords
- Cementation, Cementation techniques, Crowns, Glass-ionomer cement, Retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ziauddin UniversityUniversity, hospital or other
- Study start
- 6 Jan 2019 (actual)
- Primary completion
- 6 Sep 2019 (actual)
- Study completion
- 6 Sep 2019 (actual)
- First posted
- 25 May 2023 (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 goal of this observational study invitro study was to compare the different cementation techniques used to lute full veneer crowns on extracted and prepared teeth using Glass Ionomer Cement type 1.
The main question[s] it aims to answer are:
The in-vitro effect cement application techniques on retention of full veneer crowns.
Which of the three different cementation techniques in-vitro provide a greater retention for a full veneer crown and will it achieve better retention using the concluded method for longer duration of cemented crown in oral cavity.
To use of adequate amount of cement to avoid wastage. The principal investigator applied the Glass ionomer cement in three different techniques on custom prepared crowns and with the help of an Universal Testing Machine debonded the crown from the prepared tooth. The results were compared amongst the three categories and the technique C, proved to be the superlative amongst the three.
Detailed description
- Tooth selection The procedure started by informing the oral surgery department to reserve mandibular premolar teeth that were being extracted each day, followed by taking patient consent for the purpose of research. The extracted teeth collected were kept in hydrogen peroxide for 5 minutes and then washed under tap water for any visible debris. The teeth were then stored in Formalin 10% for a period of 7-days, as per Centers for Disease Control and Prevention disinfection protocols. The teeth were then transported in Hanks Balanced Salt solution to maintain disinfection and tooth quality.
- Preparation of tooth mounts The extracted teeth were then mounted in an acrylic block using self-cure acrylic resin (Shofu self cure acrylic resin, Japan). 0.5 mL of liquid was dispensed into a mixing cup, then 1 g of powder was added and quickly mixed using a spatula for 10 - 15 sec. Preformed plastic cylinders (Height; 55mm, Diameter; 20mm) were used, and inner walls painted with petroleum jelly for easy removal. The extracted teeth were then inserted in these cylinders filled with acrylic dough. Following manufacturer's instructions, it was ensured that the entire procedure was completed within 2 minutes after mixing was finished and at room temperature. The moulds were then left for an hour at room temperature to ensure complete chemical curing.
- Crown preparation Following complete chemical cure the teeth were prepared using a high-speed handpiece with water irrigation with diamond bur (Head Diameter: 1.2mm, Head Length: 7.7mm, 06-125µmm). They were first reduced in occlusal anatomical planes and a chamfer finish line (approximately 0.75mm) was given all around. Total Occlusal Convergence was kept at 20◦ and 25◦ with a clinical height of 5mm. Preparation dimensions (Total Occlusal Convergence, height) of the teeth were checked using computer software (AutoCAD 2000) after taking pictures with digital single-lens reflex camera with 105mm lens at 100mm. The distance was reproduced using a standard metal scale. The tooth mounts were labelled and kept in Hank's Balanced Salt Solution to maintain tissue health. Any tooth that did not meet the preparation requirements was discarded according to the Centers for Disease Control and Prevention criteria. The data collection was performed by the principal investigator. Dental photograph measurements were initially performed by the supervisor. To avoid the photographic error the photographs were calibrated by measuring the prepared tooth and scaling it on the AutoCAD software. The complete photography setup was stationary during the data collection process. Then, the data between the two operators were subjected to correlation analysis, and a strong correlation value was found (0.839). Furthermore, 20% of photographs were then re- assessed after a period of 2 weeks by the same operator. The data was analyzed later by formula to confirm intra-operator reliability through correlation statistics. As proven earlier through studies by dental morphometric measurements done by 2D image analysis can be performed by multiple operators with an excellent reliability.
- Crown fabrication Wax-up for metal crowns was done with metal extension (25mm), to engage them in the Universal Testing Machine, using Dental Inlay casting wax (Inlay wax medium stick; GC-Dental Corp. Japan). The wax up was then invested using phosphate bonded gypsum material (GC-Super, Japan) and cast with Nickel-Chromium Ni-Cr metal alloy at the Prosthodontics laboratory of Fatima Jinnah Dental College. The cast crowns were then finished used metal finishing discs, making sure the metal extensions were not less than 20mm. The fitting surface of all crowns were sandblasted accordingly and were made ready for cementation process. The teeth were numbered between 1-120 for record purposes and random assignment to either of the study groups.
- Cementation Tooth mounts were randomized using their serial numbers, to either of the three cement application techniques. This random allocation was done by generating a random sequence using Microsoft Excel by one of the department's lecturers, not directly related to the study. 40 teeth were allocated to each group. This sequence was passed on to an external operator (a general dentist), again not related to the primary research team, who was trained by the PI prior to study commencement on how to apply cement according to the operational definitions of the three cementation techniques under observation in this study. The cementation process started with mixing of permanent glass ionomer type-I luting cement (3M Ketac Cem Radiopaque Hand mix, USA) according to the manufacturer's recommendation by a single operator to ensure uniformity of mixing technique. The liquid component of Glass Ionomer Cement was measured using a 1cc syringe, while powder was measured using manufacturer provided scoop to ensure equal amount of cement was mixed. The mixing was done on a glossy paper pad provided by the manufacturer. The external operator cemented the metal crowns on the tooth mounts according to their allocation of cementation category. They were then seated by applying 80Newton pressure using a hydraulic press for 10 minutes. After ensuring the cement had dried completely the cemented crowns (on mounts) were left for seven days, soaked in distilled water to ensure hydration and to replicate intra-oral moisture conditions.
- Testing for retention On the eighth day, the PI undertook the experiment of retention testing. To help in minimizing bias while performing the retention testing, the PI and field assistant did not know which cement application technique had been used under mounted tooth being observed. The two components (Tooth mount with cemented crown) were then attached to a Universal Testing Machine (INSTRON-4301) and tensile forces were applied to check the retention of the crown. The amount of force required was monitored on the computer. The force of traction was increased slowly till the crown de-bonded and came off the prepared tooth. That value of force in Newtons was noted in the proforma against the tooth mount's serial number. The entire procedure was done under supervision of a field assistant from Pakistan Council of Scientific and Industrial Research laboratory. PI was unblinded after completion of data analysis. The serial number allocation to study groups was directly conveyed to the statistician by the external observer. All data were recorded in pre-formed proforma.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Cementation Technique AFilling the crown with cement up to margins. |
| Group B | Experimental | Other: Cementation Technique BApplying a cement layer on all fitting surfaces. |
| Group C | Experimental | Other: Cementation Technique CApplying a cement layer on all fitting surfaces except occlusal surface. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Second pre-molar tooth.
- Mandibular arch.
- Visibly sound tooth; without any pathology e.g. dental caries
- Extraction referred by Orthodontics Department.
Key exclusion criteria (4 listed)
- Carious teeth.
- Fractured or broken teeth.
- Teeth with patient history of dental anomaly.
- Teeth with any restoration e.g. filling.
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 |
|---|---|---|
| Cementation Technique A* Use of adequate amount of cement. * Prevention of wastage of cement. * Retention of crowns for longer duration. | Other | Group A |
| Cementation Technique B* Use of Sufficient Cement Quantity. * Keeping cement from going to waste. * Increased time that crowns remain in place. | Other | Group B |
| Cementation Technique C* The utilisation of an appropriate quantity of cement. * The mitigation of cement waste. * Prolonged retention of dental crowns. | Other | Group C |
Primary outcome
Cementation technique A,B and C
Time frame: 9 months
1. Filling the crown with cement up to margins. 2. Applying a cement layer on all fitting surfaces. 3. Applying a cement layer on all fitting surfaces except occlusal surface. Each of the aforementioned groups exhibits distinct measures of tensile strength. Each group will be compared with one another in terms of the cementation technique used, specifically in relation to Newton force. A questionnaire was not employed for comparative purposes among the three groups; instead, the unit of force (Newton) was utilized to compare each group.
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 25 May 2023.
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 Cementation Technique A, Cementation Technique B and Cementation Technique C in people with Cementation Teeth; Hyperplasia and Dental Cements, run by Ziauddin University at 1 site in Pakistan.
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 4 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 25 May 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 Pakistan. 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?
Cementation technique A,B and C (time frame: 9 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 25 May 2023.