Proximal ContactsPCTNCT07142746
Proximal Contact Tightness of Zirconia Crowns: Digital Intraoral Scanning vs Conventional Impressions
A study testing Digital intra oral scanning and Conventional impression in people with Proximal Contacts and Zirconia Crowns, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
Trial summary
We will be comparing the proximal contacts of zirconia crowns and adjacent natural teeth in two groups. One receiving crowns fabricated via digital intra oral scanning means. And the other group recieving crowns fabricated via the dental impression method using trays and impression material. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Proximal Contacts, Zirconia Crowns
- What is being tested?
- Digital intra oral scanning and Conventional impression
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 sitePakistan
- Study dates
- Aug 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients seeking definitive full coverage ceramic crowns for molars.
- Patients in age group of 18- 47 years.
- Patients with healthy adjacent and opposing teeth.
- Patients with healthy periodontium.
Who cannot join
- Patients with grade 1 mobility in adjacent or opposing teeth.
- Patients with diastema in posterior teeth.
- Patients having severe malocclusion associated with traumatic occlusion.
- Patients with temporomandibular joint disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Afid Rawalpindi
Rawalpindi, Punjab Province, 36000
Aleeha Dr Aleeha Zahoor Resgistrar prosthodontics, BDS, +923365003656, aleehazahoor10@gmail.com
Dr Aleeha Zahoor Dr Aleeha Zahoor Registrar Prosthodontics, BDS
About this study
Official title: Comparative Evaluation of Proximal Contact Tightness in Zirconia Crowns: Direct Digital Intraoral Scanning vs. Conventional Impressions Fabrication Method, A Randomized Control Trial.
We will be comparing the proximal contacts of zirconia crowns and adjacent natural teeth in two groups. One receiving crowns fabricated via digital intra oral scanning means. And the other group recieving crowns fabricated via the dental impression method using trays and impression material.
Read the detailed description
Subjects will be randomly assigned in two groups using a computer generated randomization list. Allocated subjects in groups will be concealed in an envelope. All clinical procedures of crown preparation and cementation will be performed by a single clinician with standard crown preparation guidelines to minimize variability. After standardized tooth preparation for full coverage ceramic crowns, one group will receive conventional impressions using polyvinyl siloxane (PVS) material in trays and other group will be scanned using intra oral digital scanner. Crowns for both groups will be fabricated in the same dental laboratory under standardized conditions.
Proximal and occlusal adjustments will be performed in the oral cavity before cementation at try in and crowns will be cemented using the same luting agent, GIC. After cementation proximal contact tightness will be assessed for the crowns by the digital force gauge at mesial and distal contacts and recorded for data compilation. The 0.05mm metal strip is inserted between the prosthesis and the adjacent natural tooth. The frictional force generated while removing the metal strip slowly in the buccal direction will be recorded on the screen of the customized digital force gauge. The frictional force generated will be considered equal to the proximal contact tightness and will be recorded in Newton (N). Proximal contact tightness will be recorded immediately after the crowns were cemented and at a recall after 10 days. These proximal contact tightness will be compared to see if there lies a significant difference in between the crowns fabricated from both impression techniques.
- Conditions
- Proximal Contacts, Zirconia Crowns
- Being tested
- Digital intra oral scanning, Conventional impression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital intra oral scanningProcedure or surgery
One groups prepared teeth will be scanned by a digital intra oral scanner.
Conventional impressionProcedure or surgery
One group will recieve impressions conventionally in a tray with dental impression polyvinly siloxane.
| Study group | Role | What they receive |
|---|---|---|
| Conventional impression | Active comparator | One group will be receiving the impression for zirconia crowns by trays and conventional impression material. Receives: Procedure: Conventional impression |
| Digital Intra Oral Scanning | Experimental | One group will recieve digital intra oral scan for obtaining digital scan of anatomy of prepared teeth. Receives: Procedure: Digital intra oral scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proximal contact tightness in terms of frictional force generated as shown on digital dynamometre in newtons at cementation day 1.
Proximal contact tightness will be assesed when shimstock will be pulled out by a hook attached to a digital dynamometre. The frictional force generated in newtons will be assesed and noted at the day 1 of cementation.
Measured: Day 1 at cementation of crown.
Secondary outcomes (1)
Proximal contact tightness of zirconia crowns in terms of frictional force in newtons as shown on digital dynamometre at the day 10.
We will assess the proximal contact tightness of zirconia crowns with adjacent teeth as we pull shimstock with a hook attached to digital dynamometre and asses the frictional force generated in Newtons at the day 10 of cementation of crown.
Measured: At 10 days after receiving the treatment crown
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal ContactsStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armed Forces Institute of Dentistry, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seema Khattak, Armed Forces Institute of Dentistry, Pakistan
- Investigators
- Dr Aleeha Zahoor Registrar Prosthodontics, Principal investigator, Armed Forces Institute of Rawalpindi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142746
- Sponsor's protocol ID
- Proximal Contact Tightness
- Acronym
- PCT
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Proximal Contact Tightness in Zirconia Crowns: Direct Digital Intraoral Scanning vs. Conventional Impressions Fabrication Method, A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT07142746
- Acronym / sponsor ID
- PCT / Proximal Contact Tightness
- Conditions
- Proximal Contacts, Zirconia Crowns
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Armed Forces Institute of Dentistry, PakistanUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 27 Aug 2025 (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.
We will be comparing the proximal contacts of zirconia crowns and adjacent natural teeth in two groups. One receiving crowns fabricated via digital intra oral scanning means. And the other group recieving crowns fabricated via the dental impression method using trays and impression material.
Detailed description
Subjects will be randomly assigned in two groups using a computer generated randomization list. Allocated subjects in groups will be concealed in an envelope. All clinical procedures of crown preparation and cementation will be performed by a single clinician with standard crown preparation guidelines to minimize variability. After standardized tooth preparation for full coverage ceramic crowns, one group will receive conventional impressions using polyvinyl siloxane (PVS) material in trays and other group will be scanned using intra oral digital scanner. Crowns for both groups will be fabricated in the same dental laboratory under standardized conditions.
Proximal and occlusal adjustments will be performed in the oral cavity before cementation at try in and crowns will be cemented using the same luting agent, GIC. After cementation proximal contact tightness will be assessed for the crowns by the digital force gauge at mesial and distal contacts and recorded for data compilation. The 0.05mm metal strip is inserted between the prosthesis and the adjacent natural tooth. The frictional force generated while removing the metal strip slowly in the buccal direction will be recorded on the screen of the customized digital force gauge. The frictional force generated will be considered equal to the proximal contact tightness and will be recorded in Newton (N). Proximal contact tightness will be recorded immediately after the crowns were cemented and at a recall after 10 days. These proximal contact tightness will be compared to see if there lies a significant difference in between the crowns fabricated from both impression techniques.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional impression | Active comparator | Procedure: Conventional impressionOne group will be receiving the impression for zirconia crowns by trays and conventional impression material. |
| Digital Intra Oral Scanning | Experimental | Procedure: Digital intra oral scanningOne group will recieve digital intra oral scan for obtaining digital scan of anatomy of prepared teeth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients seeking definitive full coverage ceramic crowns for molars.
- Patients in age group of 18- 47 years.
- Patients with healthy adjacent and opposing teeth.
- Patients with healthy periodontium.
Key exclusion criteria (4 listed)
- Patients with grade 1 mobility in adjacent or opposing teeth.
- Patients with diastema in posterior teeth.
- Patients having severe malocclusion associated with traumatic occlusion.
- Patients with temporomandibular joint disorders.
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 |
|---|---|---|
| Digital intra oral scanningOne groups prepared teeth will be scanned by a digital intra oral scanner. | Procedure or surgery | Digital Intra Oral Scanning |
| Conventional impressionOne group will recieve impressions conventionally in a tray with dental impression polyvinly siloxane. | Procedure or surgery | Conventional impression |
Primary outcome
Proximal contact tightness in terms of frictional force generated as shown on digital dynamometre in newtons at cementation day 1.
Time frame: Day 1 at cementation of crown.
Proximal contact tightness will be assesed when shimstock will be pulled out by a hook attached to a digital dynamometre. The frictional force generated in newtons will be assesed and noted at the day 1 of cementation.
1 secondary outcome
Proximal contact tightness of zirconia crowns in terms of frictional force in newtons as shown on digital dynamometre at the day 10.
Time frame: At 10 days after receiving the treatment crown
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: No
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.
Dr Aleeha Zahoor Registrar Prosthodontics principal investigator
Armed Forces Institute of Rawalpindi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital intra oral scanning and Conventional impression in people with Proximal Contacts and Zirconia Crowns, run by Armed Forces Institute of Dentistry, Pakistan 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: opening soon, as of the sponsor's last update on 27 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aleeha Dr Aleeha Zahoor, BDS (+923365003656, aleehazahoor10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proximal contact tightness in terms of frictional force generated as shown on digital dynamometre in newtons at cementation day 1. (time frame: Day 1 at cementation of crown.). 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 27 Aug 2025.