Gingival Recession, LocalizedNCT04729569
Gingival Response and Marginal Adaptation of Zirconia Crowns With Two Subgingival Margin Designs
A study testing Feather edge finish line preparation and Deep chamfer finish line preparation in people with Gingival Recession, Localized, run by Cairo University.
Trial summary
The aim of the study is to evaluate the effect of feather edge finish line and deep chamfer finish line on gingival position, bleeding on probing and marginal adaptation. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Localized
- What is being tested?
- Feather edge finish line preparation and Deep chamfer finish line preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 1 Dec 2022
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients 18 years to 50 years old
- Dentate patients planned for a single full coverage restoration in the posterior area.
- Patients with no active periodontal disease.
- >2mm of keratinized tissue
Who cannot join
- Smoking (>10 cigarettes a day)
- Substance abuse history
- Patients with poor oral hygiene and high caries index
- Patients suffering from abnormal occlusal habits for example clenching or bruxism
- Local or systemic disease (endocrine, renal, hematologic, hepatic, immunosuppressive)
- Current steroid/chemotherapy
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- Head and neck irradiation
- Pregnancy
- Inability or unwillingness to return for follow up visits.
About this study
Official title: Gingival Response and Marginal Adaptation of Zirconia Crowns With Two Subgingival Margin Designs: A Randomized Clinical Trial
The aim of the study is to evaluate the effect of feather edge finish line and deep chamfer finish line on gingival position, bleeding on probing and marginal adaptation.
Read the detailed description
The aim of the study is to evaluate the effect of feather edge finish line and deep chamfer finish line on gingival position, bleeding on probing and marginal adaptation.
Gingival bleeding on probing will be evaluated before treatment. Preparation for all ceramic full coverage restoration will be performed according to manufacturer instructions by one operator. Type of finish line (whether feather edge or deep chamfer finish line) will be selected randomly according to a computer generated randomization list. Restorative margins will be placed subgingivally. Zirconia crowns will be fabricated for the prepared teeth and cemented using resin luting agent. At 6 months and 12 months after the cementation, restorative margin position relative to the gingival margin will be recorded. Bleeding on probing and marginal adaptation will also be recorded.
- Conditions
- Gingival Recession, Localized
- Being tested
- Feather edge finish line preparation, Deep chamfer finish line preparation
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feather edge finish line preparationProcedure or surgery
Tooth preparation with feather edge finish line will be done to posterior teeth to receive all ceramic full coverage zirconia crowns.
Deep chamfer finish line preparationProcedure or surgery
Tooth preparation with deep chamfer finish line will be done to posterior teeth to receive all ceramic full coverage zirconia crowns.
| Study group | Role | What they receive |
|---|---|---|
| Tested finish line preparation | Other | Feather edge finish line preparation (Intervention) Receives: Procedure: Feather edge finish line preparation |
| Comparator finish line preparation | Active comparator | Deep chamfer finish line preparation (Comparator) Receives: Procedure: Deep chamfer finish line preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Position of the margin of the restoration in relation to the gingival margin position
Scoring proposed by Paniz et al classified into either subgingival (not visible), equigingival (slightly visible) and supragingival (visible)
Measured: 1 year
Secondary outcomes (1)
Bleeding on probing
Scoring following Ainamo and Bay gingival bleeding index
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival Recession, LocalizedStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Ahmed Hassan El-Khayat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729569
- Sponsor's protocol ID
- 161020
- Status last verified
- Jul 2021
- First submitted
- 24 Jan 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
El-Khayat H, Anwar EM, Nabil O, Aboushahba M. Gingival Recession and Marginal Adaptation of Zirconia Crowns with Two Subgingival Margin Designs: A Randomized Clinical Trial. J Contemp Dent Pract. 2025 Aug 1;26(8):767-775. doi: 10.5005/jp-journals-10024-3932.
PubMed 41145363
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Response and Marginal Adaptation of Zirconia Crowns With Two Subgingival Margin Designs: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04729569
- Acronym / sponsor ID
- 161020
- Conditions
- Gingival Recession, Localized
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 28 Jan 2021 (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 aim of the study is to evaluate the effect of feather edge finish line and deep chamfer finish line on gingival position, bleeding on probing and marginal adaptation.
Detailed description
The aim of the study is to evaluate the effect of feather edge finish line and deep chamfer finish line on gingival position, bleeding on probing and marginal adaptation.
Gingival bleeding on probing will be evaluated before treatment. Preparation for all ceramic full coverage restoration will be performed according to manufacturer instructions by one operator. Type of finish line (whether feather edge or deep chamfer finish line) will be selected randomly according to a computer generated randomization list. Restorative margins will be placed subgingivally. Zirconia crowns will be fabricated for the prepared teeth and cemented using resin luting agent. At 6 months and 12 months after the cementation, restorative margin position relative to the gingival margin will be recorded. Bleeding on probing and marginal adaptation will also be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tested finish line preparation | Other | Procedure: Feather edge finish line preparationFeather edge finish line preparation (Intervention) |
| Comparator finish line preparation | Active comparator | Procedure: Deep chamfer finish line preparationDeep chamfer finish line preparation (Comparator) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients 18 years to 50 years old
- Dentate patients planned for a single full coverage restoration in the posterior area.
- Patients with no active periodontal disease.
- >2mm of keratinized tissue
Key exclusion criteria (9 listed)
- Smoking (>10 cigarettes a day)
- Substance abuse history
- Patients with poor oral hygiene and high caries index
- Patients suffering from abnormal occlusal habits for example clenching or bruxism
- Local or systemic disease (endocrine, renal, hematologic, hepatic, immunosuppressive)
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 |
|---|---|---|
| Feather edge finish line preparationTooth preparation with feather edge finish line will be done to posterior teeth to receive all ceramic full coverage zirconia crowns. | Procedure or surgery | Tested finish line preparation |
| Deep chamfer finish line preparationTooth preparation with deep chamfer finish line will be done to posterior teeth to receive all ceramic full coverage zirconia crowns. | Procedure or surgery | Comparator finish line preparation |
Primary outcome
Position of the margin of the restoration in relation to the gingival margin position
Time frame: 1 year
Scoring proposed by Paniz et al classified into either subgingival (not visible), equigingival (slightly visible) and supragingival (visible)
1 secondary outcome
Bleeding on probing
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Derived from this study: PubMed 41145363El-Khayat H, Anwar EM, Nabil O, Aboushahba M. Gingival Recession and Marginal Adaptation of Zirconia Crowns with Two Subgingival Margin Designs: A Randomized Clinical Trial. J Contemp Dent Pract. 2025 Aug 1;26(8):767-775. doi: 10.5005/jp-journals-10024-3932.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Feather edge finish line preparation and Deep chamfer finish line preparation in people with Gingival Recession, Localized, 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 4 inclusion and 9 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 28 Jul 2021. 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?
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?
Position of the margin of the restoration in relation to the gingival margin position (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04729569, which also lists 1 linked publication.
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 28 Jul 2021.