Altered Passive Eruption of TeethNCT05478317
Esthetic Crown Lengthening With Closed Piezoelectric in Comparison to Open Flap Approach
A study testing ECL- mPZ and ECL-OF in people with Altered Passive Eruption of Teeth, run by Augusta University at 1 site in United States.
Trial summary
In this randomized clinical trial, the investigators are comparing two different approaches for Esthetic crown lengthening- a minimally invasive approach using piezoelectric (PZ) and a traditional open flap approach (OF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Altered Passive Eruption of Teeth
- What is being tested?
- ECL- mPZ and ECL-OF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2022to 18 Jan 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a gummy smile due to APE (Type 1B) in two or more maxillary anterior teeth
- Patients with normal muscular efficiency of the upper lip
- Patients with no vertical skeletal defects
Who cannot join
- Patients with systemic condition that prevent periodontal surgery
- Patients who smoke
- Patients with previous periodontal surgery in the same area
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Augusta University-Dental College of Georgia
Augusta, Georgia, 30912
Ahmed El-Awady, BDS, MS, PhD, 706-721-5755, aelawady@augusta.edu
Jaspreet Farmaha, PhD, 7067211270, jfarmaha@augusta.edu
About this study
In this randomized clinical trial, the investigators are comparing two different approaches for Esthetic crown lengthening- a minimally invasive approach using piezoelectric (PZ) and a traditional open flap approach (OF).
Read the detailed description
The altered passive eruption is diagnosed when there is an excessive gingival display with short clinical crowns. Esthetic crown lengthening (ECL) is the most common surgical treatment of altered passive eruption. Traditional ECL involves osseous resection with gingivectomy or apical displaced gingiva. The amount of soft and hard tissue removal in this technique aims to provide a healthy and esthetically acceptable crown height. However, gingival tissue coronal rebound is one of the most noted post-operative complications of traditionally used techniques. On the other hand, surgical techniques that include flap reflection may cause more coronal displacement of the gingival margin. Hence, it is crucial to assess different surgical techniques to determine the most effective technique that gives the required outcomes with maximum patient satisfaction.
Piezoelectric bone surgery delivers high precision in resection, good tactile sensibility, and permits a selective cut of mineralized tissue while sparing soft tissue. Further, the minimally invasive technique (mECL) was suggested to reduce pain, post-op discomfort, and procedure duration, and to accelerate the healing process. The mECL technique conveys a potential alternative approach as a sutureless, atraumatic, and less invasive technique that has been shown to increase patient satisfaction and comfort. In addition, using piezoelectric for osseous resection in this closed approach increases the favorable surgical outcomes. However, the osseous resection in mECL may be incomplete and results in a coronal rebound on the gingival contour. In addition, osseous resection in this approach is very technique sensitive to avoid root damage and uneven bone resection. A few studies and even a fewer clinical trials evaluated the clinical outcome of mECL using piezoelectric for osseous resection (PZ). Hence, in this randomized clinical trial, gingival margin and bone crest stability will be evaluated after a minimally invasive approach using piezoelectric (PZ) and a traditional open flap approach (OF).
- Conditions
- Altered Passive Eruption of Teeth
- Being tested
- ECL- mPZ, ECL-OF
- Keywords
- Crown lengthening, Open-flap approach, Piezoelectric approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECL- mPZProcedure or surgery
Flapless Technique using Piezoelectric (PZ):
Gingivectomy and intra-sulcular incision will be carried out to remove strip of outlined marginal gingiva. However, no flap will be reflected the osseous recontouring will be carried using special piezoelectric tip below gingival margin. The required distance between the bone crest and the gingival margin will be checked by inserting a periodontal probe into the incision below gingival margin.
ECL-OFProcedure or surgery
Open Flap Technique (OF):
Gingivectomy and intra-sulcular incision will be carried out to remove strip of outlined marginal gingiva. Full mucoperiosteal flap will be elevated to preform ostectomy and/or osteoplasty until the desired distance achieved between the bone crest and the gingival margin. After achieving the new supracrestal distance, the flap will be sutured.
| Study group | Role | What they receive |
|---|---|---|
| Control group: Crown lengthening using a traditional open-flap approach (OF). | Active comparator | Esthetic Crown lengthening done using a traditional open-flap approach (OF). Receives: Procedure: ECL-OF |
| Test group: Crown lengthening using a minimally invasive approach by piezoelectric (PZ). | Experimental | Esthetic Crown lengthening done using a minimally invasive approach using piezoelectric (PZ). Receives: Procedure: ECL- mPZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of supracrestal width (cementoenamel junction to alveolar crest CEJ-AC)
Change of the supracrestal width will be measured using cone beam computed tomography (CBCT).
Measured: CBCT parameter will be evaluated before the surgery and at 12 month after the surgery.
Secondary outcomes (3)
Change on Probing depth (PD)
Change on Probing depth (PD)
Measured: PD will be evaluated prior to surgery and 6 and 12 month after surgery
Change on Bleeding on probing (BOP)
Change on Bleeding on probing (BOP)
Measured: BOP will be evaluated prior to surgery and 6 and 12 month after surgery
Change clinical attachment level (CAL).
Change on clinical attachment level (CAL).
Measured: CAL will be evaluated prior to surgery and 6 and 12 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start18 May 2022
- Primary completion18 Jan 2025 (estimated)
- Study completion18 Jan 2025 (estimated)
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
- Model description
- Subjects' matching inclusion criteria will be randomly assigned to control (OF) or tested (PZ) groups. After eligibility has been ascertained and consent has been obtained, subjects planned for ECL will be enrolled in the study and assigned to the group in 1:1 ratio using computer-generated block randomization scheme.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed El-Awady, Augusta University
- Investigators
- Ahmed El-Awady, BDS, MS, PHD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478317
- Sponsor's protocol ID
- 1807704
- Status last verified
- Jul 2022
- First submitted
- 19 Jul 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esthetic Crown Lengthening With Closed Piezoelectric in Comparison to Open Flap Approach
- ClinicalTrials.gov ID
- NCT05478317
- Acronym / sponsor ID
- 1807704
- Conditions
- Altered Passive Eruption of Teeth
- Keywords
- Crown lengthening, Open-flap approach, Piezoelectric approach
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- 18 Jan 2025 (estimated)
- Study completion
- 18 Jan 2025 (estimated)
- First posted
- 28 Jul 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.
In this randomized clinical trial, the investigators are comparing two different approaches for Esthetic crown lengthening- a minimally invasive approach using piezoelectric (PZ) and a traditional open flap approach (OF).
Detailed description
The altered passive eruption is diagnosed when there is an excessive gingival display with short clinical crowns. Esthetic crown lengthening (ECL) is the most common surgical treatment of altered passive eruption. Traditional ECL involves osseous resection with gingivectomy or apical displaced gingiva. The amount of soft and hard tissue removal in this technique aims to provide a healthy and esthetically acceptable crown height. However, gingival tissue coronal rebound is one of the most noted post-operative complications of traditionally used techniques. On the other hand, surgical techniques that include flap reflection may cause more coronal displacement of the gingival margin. Hence, it is crucial to assess different surgical techniques to determine the most effective technique that gives the required outcomes with maximum patient satisfaction.
Piezoelectric bone surgery delivers high precision in resection, good tactile sensibility, and permits a selective cut of mineralized tissue while sparing soft tissue. Further, the minimally invasive technique (mECL) was suggested to reduce pain, post-op discomfort, and procedure duration, and to accelerate the healing process. The mECL technique conveys a potential alternative approach as a sutureless, atraumatic, and less invasive technique that has been shown to increase patient satisfaction and comfort. In addition, using piezoelectric for osseous resection in this closed approach increases the favorable surgical outcomes. However, the osseous resection in mECL may be incomplete and results in a coronal rebound on the gingival contour. In addition, osseous resection in this approach is very technique sensitive to avoid root damage and uneven bone resection. A few studies and even a fewer clinical trials evaluated the clinical outcome of mECL using piezoelectric for osseous resection (PZ). Hence, in this randomized clinical trial, gingival margin and bone crest stability will be evaluated after a minimally invasive approach using piezoelectric (PZ) and a traditional open flap approach (OF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects' matching inclusion criteria will be randomly assigned to control (OF) or tested (PZ) groups. After eligibility has been ascertained and consent has been obtained, subjects planned for ECL will be enrolled in the study and assigned to the group in 1:1 ratio using computer-generated block randomization scheme.
| Arm | Type | Receives |
|---|---|---|
| Control group: Crown lengthening using a traditional open-flap approach (OF). | Active comparator | Procedure: ECL-OFEsthetic Crown lengthening done using a traditional open-flap approach (OF). |
| Test group: Crown lengthening using a minimally invasive approach by piezoelectric (PZ). | Experimental | Procedure: ECL- mPZEsthetic Crown lengthening done using a minimally invasive approach using piezoelectric (PZ). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a gummy smile due to APE (Type 1B) in two or more maxillary anterior teeth
- Patients with normal muscular efficiency of the upper lip
- Patients with no vertical skeletal defects
Key exclusion criteria (4 listed)
- Patients with systemic condition that prevent periodontal surgery
- Patients who smoke
- Patients with previous periodontal surgery in the same area
- Pregnant women
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 |
|---|---|---|
| ECL- mPZFlapless Technique using Piezoelectric (PZ): Gingivectomy and intra-sulcular incision will be carried out to remove strip of outlined marginal gingiva. However, no flap will be reflected the osseous recontouring will be carried using special piezoelectric tip below gingival margin. The required distance between the bone crest and the gingival margin will be checked by inserting a periodontal probe into the incision below gingival margin. | Procedure or surgery | Test group: Crown lengthening using a minimally invasive approach by piezoelectric (PZ). |
| ECL-OFOpen Flap Technique (OF): Gingivectomy and intra-sulcular incision will be carried out to remove strip of outlined marginal gingiva. Full mucoperiosteal flap will be elevated to preform ostectomy and/or osteoplasty until the desired distance achieved between the bone crest and the gingival margin. After achieving the new supracrestal distance, the flap will be sutured. | Procedure or surgery | Control group: Crown lengthening using a traditional open-flap approach (OF). |
Primary outcome
Change of supracrestal width (cementoenamel junction to alveolar crest CEJ-AC)
Time frame: CBCT parameter will be evaluated before the surgery and at 12 month after the surgery.
Change of the supracrestal width will be measured using cone beam computed tomography (CBCT).
3 secondary outcomes
Change on Probing depth (PD)
Time frame: PD will be evaluated prior to surgery and 6 and 12 month after surgery
Change on Bleeding on probing (BOP)
Time frame: BOP will be evaluated prior to surgery and 6 and 12 month after surgery
Change clinical attachment level (CAL).
Time frame: CAL will be evaluated prior to surgery and 6 and 12 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Altered Passive Eruption of Teeth
Enrolling by invitation
Laser-Assisted Minimally Invasive Esthetic Crown Lengthening Using Flapless vs. Tunneled Flap Approach
Altered Passive Eruption of Teeth
RecruitingObservational study
Gummy Smile and Altered Passive Eruption Prevalence
Altered Passive Eruption of Teeth
Active, not recruiting
Clinical Evaluation of Gingivalstat Approach Compared to Conventional Esthetic Crown Lengthening on the Stability of The Gingival Margin in Patients With Altered Passive Eruption.
Gummy Smile, Altered Passive Eruption of Teeth
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.
Ahmed El-Awady, BDS, MS, PHD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECL- mPZ and ECL-OF in people with Altered Passive Eruption of Teeth, run by Augusta University at 1 site in United States.
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 3 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: status not confirmed, as of the sponsor's last update on 1 Aug 2022. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed El-Awady, BDS, MS, PHD (706-721-5755, aelawady@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of supracrestal width (cementoenamel junction to alveolar crest CEJ-AC) (time frame: CBCT parameter will be evaluated before the surgery and at 12 month after the surgery.). 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 1 Aug 2022.