Gummy SmileNCT03804281
Clinical Evaluation of Conventional Versus Microsurgical Techniques of Esthetic Crown Lengthening
A study testing Test group in people with Gummy Smile, run by Cairo University.
Trial summary
the study compare gingival margin stability following conventional approach versus microsurgical approach of esthetic crown lengthening in management of patients with short clinical crowns in the upper anterior region.In management of patients with short clinical crowns in the upper anterior region, there is no… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gummy Smile
- What is being tested?
- Test group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2019to 1 Aug 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with healthy systemic condition.
- Adult patients ˃ 18 years old.
- The presence of the six upper anterior teeth.
- Absence of sites with attachment loss and probing depth (PD) >3 mm
- Keratinized gingiva of at least 2mm width.
- Compliance with good oral hygiene.
- Patients accepts 6-months follow-up period (cooperative patients).
- Patients provides an informed consent
Who cannot join
- Gummy smile with normal tooth proportions
- Presence of prosthetic crowns
- Extensive restorations
- Extensive incisal edge attrition.
- Misalignment on maxillary anterior teeth.
- Smokers ˃ 10 cigarettes / day.
About this study
Official title: Clinical Evaluation of Gingival Margin Stability Following Conventional Versus Microsurgical Techniques of Esthetic Crown Lengthening
the study compare gingival margin stability following conventional approach versus microsurgical approach of esthetic crown lengthening in management of patients with short clinical crowns in the upper anterior region.In management of patients with short clinical crowns in the upper anterior region, there is no difference in gingival margin stability between conventional and microsurgical approaches of esthetic crown lengthening.
- Conditions
- Gummy Smile
- Being tested
- Test group, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test groupProcedure or surgery
The surgery will be done with the use of 4x magnification loop, the knives are micro blades and micro-sutures 7//0 used with the microsurgical instruments kit
Control groupProcedure or surgery
esthetic crown lengthening with conventional approach with an internal bevel incision, following CEJ anatomy, this will be followed by an intra-sulcular incision, removal of the strip of outlined marginal gingiva and elevation of a mucoperiosteal flap to the level of the alveolar bone crest.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | esthetic crown lengthening with microsurgical approach Receives: Procedure: Test group |
| Control group | Active comparator | esthetic crown lengthening with conventional approach. Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mid-buccal gingival margin level
periodontal probe with William's graduation will be used to measure the distance from the CEJ to the gingival margin at the mid-buccal surface
Measured: 6 months
Secondary outcomes (3)
Pink Esthetic Score (PES)
The PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture. Each variable shall be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The mesial and distal papilla will be evaluated for completeness, incompleteness or absence
Measured: 6 months
Post-Surgical swelling
will be evaluated post-surgically with Verbal Rating Scale with words ranging from (absent-slight-moderate-intense) Absent (no swelling), Slight (intraoral swelling at the operated area), Moderate (moderate intraoral swelling at the operated area) and Intense (intensive extra oral swelling extending beyond the operated area).
Measured: 7days
Post-Surgical Patient Satisfaction: 3-item questionnaire
A 3-item questionnaire is asked and the patients shall use a 7-point answer scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start1 Feb 2019 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gummy SmileStudies 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
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed elshafie mohamed tawfiq hassan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804281
- Sponsor's protocol ID
- Dentaris192018
- Status last verified
- Jan 2019
- First submitted
- 11 Jan 2019
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Gingival Margin Stability Following Conventional Versus Microsurgical Techniques of Esthetic Crown Lengthening
- ClinicalTrials.gov ID
- NCT03804281
- Acronym / sponsor ID
- Dentaris192018
- Conditions
- Gummy Smile
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 15 Jan 2019 (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 study compare gingival margin stability following conventional approach versus microsurgical approach of esthetic crown lengthening in management of patients with short clinical crowns in the upper anterior region.In management of patients with short clinical crowns in the upper anterior region, there is no difference in gingival margin stability between conventional and microsurgical approaches of esthetic crown lengthening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Procedure: Test groupesthetic crown lengthening with microsurgical approach |
| Control group | Active comparator | Procedure: Control groupesthetic crown lengthening with conventional approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with healthy systemic condition.
- Adult patients ˃ 18 years old.
- The presence of the six upper anterior teeth.
- Absence of sites with attachment loss and probing depth (PD) >3 mm
- Keratinized gingiva of at least 2mm width.
Key exclusion criteria (6 listed)
- Gummy smile with normal tooth proportions
- Presence of prosthetic crowns
- Extensive restorations
- Extensive incisal edge attrition.
- Misalignment on maxillary anterior teeth.
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 |
|---|---|---|
| Test groupThe surgery will be done with the use of 4x magnification loop, the knives are micro blades and micro-sutures 7//0 used with the microsurgical instruments kit | Procedure or surgery | Test group |
| Control groupesthetic crown lengthening with conventional approach with an internal bevel incision, following CEJ anatomy, this will be followed by an intra-sulcular incision, removal of the strip of outlined marginal gingiva and elevation of a mucoperiosteal flap to the level of the alveolar bone crest. | Procedure or surgery | Control group |
Primary outcome
Mid-buccal gingival margin level
Time frame: 6 months
periodontal probe with William's graduation will be used to measure the distance from the CEJ to the gingival margin at the mid-buccal surface
3 secondary outcomes
Pink Esthetic Score (PES)
Time frame: 6 months
Post-Surgical swelling
Time frame: 7days
Post-Surgical Patient Satisfaction: 3-item questionnaire
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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 Test group in people with Gummy Smile, 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 8 inclusion and 6 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 18 Jan 2019. 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?
Mid-buccal gingival margin level (time frame: 6 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 18 Jan 2019.