Altered Passive Eruption of TeethNCT05512312
Computer Guided Esthetic Crown Lengthening
A study testing Conventional Esthetic crown lengthening and Computer guided Esthetic crown lengthening in people with Altered Passive Eruption of Teeth and Guided Surgery, run by Ain Shams University at 1 site in Egypt.
Trial summary
The objective of the present study was to evaluate the effectiveness of surgical esthetic crown lengthening using digitally assisted 3D printed surgical stents in management of excessive gingival display due to altered passive eruption. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Altered Passive Eruption of Teeth, Guided Surgery, Gummy Smile
- What is being tested?
- Conventional Esthetic crown lengthening and Computer guided Esthetic crown lengthening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2022to 12 Oct 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females within age range of 20-40 years.
- Systemic (medically) free individuals.
- Excessive gingival display in the esthetic zone (more than 3mm of gingival display at full smiling)
- Patients with good oral hygiene.
Who cannot join
- Smokers (15)
- Teeth with compromised periodontium.
- Pregnant and lactating females.
- The vulnerable group: patients with mental or physical disabilities.
- Patients with parafunctional habits.
- Medications that affect periodontal wound healing.
- Periodontal surgery in the esthetic zone in the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Excessive Gingival Display Using Conventional Esthetic Crown Lengthening Versus Computer Guided Esthetic Crown Lengthening: (A Randomized Clinical Trial)
The objective of the present study was to evaluate the effectiveness of surgical esthetic crown lengthening using digitally assisted 3D printed surgical stents in management of excessive gingival display due to altered passive eruption.
Read the detailed description
The objective of the present study was to evaluate the effectiveness of surgical esthetic crown lengthening using digitally assisted 3D printed surgical stents in management of excessive gingival display due to altered passive eruption.
Primary objectives:
Wound healing Score: the clinical features of periodontal wound healing were measured according to Hagenaars et al using the following parameters: swelling of the soft tissue , color of the gingiva, probing pocket depth, bleeding index, plaque index, clinical attachment level. These signs were assessed at 1 week, 3 months and 6 months post-operative.
Operating time: the time needed to complete each procedure was calculated in minutes by using a stopwatch from the time of the first incision till the completion of bone removal.
Secondary objectives:
Patient satisfaction: was assessed using visual analogue scale at 24 hours, 7 days and 14 days post operatively. (Zero is for minimum pain and ten is for maximum pain).
Gingival margin stability: The position of gingival margin in relation to a reference point was evaluated immediately after surgery, 3 months and 6 months healing period .
- Being tested
- Conventional Esthetic crown lengthening, Computer guided Esthetic crown lengthening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Esthetic crown lengtheningProcedure or surgery
Conventional Surgical Esthetic Crown Lengthening
Computer guided Esthetic crown lengtheningProcedure or surgery
Computer guided Esthetic crown lengthening
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Active comparator | Eight patients indicated for ECL were treated using digitally assisted crown lengthening utilizing 3D printed surgical stents. Receives: Procedure: Computer guided Esthetic crown lengthening |
| Control Group | Active comparator | Eight patients indicated for ECL were managed by conventional crown lengthening. Receives: Procedure: Conventional Esthetic crown lengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing
the clinical features of periodontal wound healing were measured according to Hagenaars et al using the following parameters: color of the gingiva (C) (a score of 0-2) 0=no redness, 1=moderate redness, 2=pronounced redness
Measured: Change in soft tissue features from 1 week to 6 months post operative
Operating time
the time needed to complete each procedure from the first incision till the completion of bone removal
Measured: During surgery
Secondary outcomes (2)
Patient satisfaction
will be assessed using numerical visual analogue scale (scale of zero - no pain to ten- maximum pain)
Measured: 1 day - 1 week - 2 weeks post operative
Gingival margin stability
The position of gingival margin in reference to an index is measured from the incisal edge to the free gingival margin
Measured: Baseline - 3 months post operative - 6 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start2 Jan 2022
- Primary completion10 Sep 2022
- Study completion12 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Altered Passive Eruption of TeethStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Borham, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512312
- Sponsor's protocol ID
- Guided gummy smile correction
- Status last verified
- Dec 2022
- First submitted
- 5 Jun 2022
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Excessive Gingival Display Using Conventional Esthetic Crown Lengthening Versus Computer Guided Esthetic Crown Lengthening: (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT05512312
- Acronym / sponsor ID
- Guided gummy smile correction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 10 Sep 2022 (actual)
- Study completion
- 12 Oct 2022 (actual)
- First posted
- 23 Aug 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.
The objective of the present study was to evaluate the effectiveness of surgical esthetic crown lengthening using digitally assisted 3D printed surgical stents in management of excessive gingival display due to altered passive eruption.
Detailed description
The objective of the present study was to evaluate the effectiveness of surgical esthetic crown lengthening using digitally assisted 3D printed surgical stents in management of excessive gingival display due to altered passive eruption.
Primary objectives:
Wound healing Score: the clinical features of periodontal wound healing were measured according to Hagenaars et al using the following parameters: swelling of the soft tissue , color of the gingiva, probing pocket depth, bleeding index, plaque index, clinical attachment level. These signs were assessed at 1 week, 3 months and 6 months post-operative.
Operating time: the time needed to complete each procedure was calculated in minutes by using a stopwatch from the time of the first incision till the completion of bone removal.
Secondary objectives:
Patient satisfaction: was assessed using visual analogue scale at 24 hours, 7 days and 14 days post operatively. (Zero is for minimum pain and ten is for maximum pain).
Gingival margin stability: The position of gingival margin in relation to a reference point was evaluated immediately after surgery, 3 months and 6 months healing period .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Active comparator | Procedure: Computer guided Esthetic crown lengtheningEight patients indicated for ECL were treated using digitally assisted crown lengthening utilizing 3D printed surgical stents. |
| Control Group | Active comparator | Procedure: Conventional Esthetic crown lengtheningEight patients indicated for ECL were managed by conventional crown lengthening. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and females within age range of 20-40 years.
- Systemic (medically) free individuals.
- Excessive gingival display in the esthetic zone (more than 3mm of gingival display at full smiling)
- Patients with good oral hygiene.
Key exclusion criteria (7 listed)
- Smokers (15)
- Teeth with compromised periodontium.
- Pregnant and lactating females.
- The vulnerable group: patients with mental or physical disabilities.
- Patients with parafunctional habits.
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 |
|---|---|---|
| Conventional Esthetic crown lengtheningConventional Surgical Esthetic Crown Lengthening | Procedure or surgery | Control Group |
| Computer guided Esthetic crown lengtheningComputer guided Esthetic crown lengthening | Procedure or surgery | Test Group |
Primary outcome
Wound Healing
Time frame: Change in soft tissue features from 1 week to 6 months post operative
the clinical features of periodontal wound healing were measured according to Hagenaars et al using the following parameters: color of the gingiva (C) (a score of 0-2) 0=no redness, 1=moderate redness, 2=pronounced redness
Operating time
Time frame: During surgery
the time needed to complete each procedure from the first incision till the completion of bone removal
2 secondary outcomes
Patient satisfaction
Time frame: 1 day - 1 week - 2 weeks post operative
Gingival margin stability
Time frame: Baseline - 3 months post operative - 6 months post operative
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 3 Apr 2023.
Related trials for Altered Passive Eruption of Teeth
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Altered Passive Eruption of Teeth
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Clinical Evaluation of Gingivalstat Approach Compared to Conventional Esthetic Crown Lengthening on the Stability of The Gingival Margin in Patients With Altered Passive Eruption.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Esthetic crown lengthening and Computer guided Esthetic crown lengthening in people with Altered Passive Eruption of Teeth and Guided Surgery, run by Ain Shams University at 1 site in Egypt.
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 7 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 3 Apr 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 Egypt. 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?
Wound Healing (time frame: Change in soft tissue features from 1 week to 6 months post operative). The study lists 2 primary outcomes in all. 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 3 Apr 2023.