Gummy SmileNCT07041541
Clinical Evaluation of Gingivalstat Approach Compared to Conventional Esthetic Crown Lengthening on the Stability of The Gingival Margin in Patients With Altered Passive Eruption.
A study testing Esthetic Crown Lengthening and Esthetic Crown Lengthening using GingivalStat approach in people with Gummy Smile and Altered Passive Eruption of Teeth, run by Cairo University at 1 site in Egypt.
Trial summary
When performing crown lengthening surgery, especially in the esthetic zone, the positional stability of gingival tissues is considered a prime important goal. The rebound of gingival margins after surgery can result in compromising the esthetic outcome and patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gummy Smile, Altered Passive Eruption of Teeth, Healthy Participants
- What is being tested?
- Esthetic Crown Lengthening and Esthetic Crown Lengthening using GingivalStat approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Oct 2024to 1 Jun 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with Altered Passive Eruption Subtype B presenting altered alveolar bone crest-CEJ relationship according to Coslet's et al. classification.
- Patients free of systemic diseases.
- Patients aged between 18 to 60 years old.
- Patients maintaining good oral hygiene with full-mouth plaque and bleeding scores <15%.
- Patients should be committed to the post-operative care regime, including oral hygiene practices, and follow-up visits.
Who cannot join
- Areas in which the remaining amount of keratinized gingiva after the submarginal incision will be less than 3 mm.
- Patients with periodontal disease.
- Smokers.
- Pregnant women.
- Patients on medication that may interfere with healing (corticosteroids, bisphosphonate, Chemo/radiotherapy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Gingivalstat Approach Compared to Conventional Esthetic Crown Lengthening on the Stability of The Gingival Margin in Patients With Altered Passive Eruption. A Randomized Clinical Trial.
When performing crown lengthening surgery, especially in the esthetic zone, the positional stability of gingival tissues is considered a prime important goal. The rebound of gingival margins after surgery can result in compromising the esthetic outcome and patient satisfaction. It was proven throughout the literature that there are many factors that may influence the stability of gingival margin position after surgery such as: the surgical technique being performed, experience of the clinician, periodontal phenotype and distance of flap with respect to the alveolar crest.
Read the detailed description
A "gummy smile" or excessive gingival display (EGD) is when at least 3-5 mm of gingiva is visible. It is viewed as unnatural or unsightly, and in order to have the best outcome, cosmetic periodontal recontouring is frequently necessary. It is considered the treatment of choice for excessive gingival display, or "Gummy smile,". Many causes of gummy smiles have been found, including altered passive eruption, short upper lip, dentoalveolar extrusion, abnormal vertical bone growth, and a combination of some of these.
Altered passive eruption is when the gingival margin is located incisal to the cervical convexity of the crown and away from the cemento-enamel junction of the tooth. It is considered the most frequent related factor, accounting for between 12.1 and 35.8% of excessive gingival display cases that have been identified, according to evidence.
Considering esthetic crown lengthening (ECL) surgery, the goal is to restore the gingival harmony and symmetry by reestablishing the proper clinical crown length. However, stability of the periodontal tissues after ECL is a crucial aspect that can be jeopardized the treatment outcome of the treated region. In particular, gingival margin rebound can impair aesthetics and have an impact on the health of periodontal tissue
Predicting the amount of tissue rebound after esthetic crown lengthening surgery is still controversial. According to literature, there is a tendency to have a gingival regrowth from the immediate postoperative level for up to 3 months. It has been also confirmed that rebound of gingival margin most likely occurs during the first three months following surgery. Another study found that the gingival margin had coronal migration may continue for up to 6-12 months after surgery.
Based on current evidence, gingival margin rebound is a major issue that happens after performing crown lengthening surgery. To avoid this, GingivalStat approach has been proposed to guide the tissue after surgery to remodel early at a predetermined position and avoid the re-growth of gingiva in a coronal direction. It appears to be producing earlier stability. The current study aims to investigate the influence of GingivalStat following crown lengthening versus conventional crown lengthening, in terms of stability of gingival margin.
- Being tested
- Esthetic Crown Lengthening, Esthetic Crown Lengthening using GingivalStat approach
- Keywords
- Gummy Smile, Altered Passive Eurption, Esthetic Crown Lengthening, GingivalStat Approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esthetic Crown LengtheningProcedure or surgery
Conventional Esthetic Crown Lengthening
Esthetic Crown Lengthening using GingivalStat approachProcedure or surgery
Esthetic Crown Lengthening using GingivalStat approach (composite stops)
| Study group | Role | What they receive |
|---|---|---|
| Interventional group (Gingival Stat approach -- Composite stops after ECL surgery) | Experimental | Steps 1-6 as Active Comparator group + 7. Resin composite wil be placed on the cervical third of the teeth, following the CEJ anatomy, to act as a gingival stabilizer to guide the early remodelling of tissues.
8. Removal of sutures and composite after two weeks. Receives: Procedure: Esthetic Crown Lengthening using GingivalStat approach |
| Control group (Conventional ECL surgery) | Active comparator | 1. Following the administration of local anaesthesia, a submarginal internal bevelled incision using 15c blade will be carried out, from canine to canine. The distance from the gingival margin will be based on how much soft tissue needs to be removed to meet the ideal tooth proportion.
2. Intrasulcular incision will be done in the buccal aspect and papilla region for removal of tissue collar.
3. A full thickness mucoperiosteal flap will be elevated using mucoperiosteal elevator, without bypassing the MGJ.
4. To obtain a 3 mm distance between CEJ and bone, osteoctomy wil be carried out from line angle to line angle using high speed hand piece with end-cutting bur.
5. Osteoplasty using round bur, maybe done to reduce bone thickness and obtain adequate anatomical profile.
6. After the flap is repositioned, interrupted sutures using Polypropylene 5-0 will be used to adapt and suture the flap in its new position. Receives: Procedure: Esthetic Crown Lengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the gingival margin
Gingival margin position wil be measured using UNC periodontal probe + stent. Grooves will be made in the stent to standardize probe direction and localization. Each tooth will be assessed on the mesio-buccal, mid-buccal, and disto-buccal aspect at baseline, immediate post operative, 2 weeks, 3 months, and 6 months.
Measured: Baseline, immediate post operative, 2 weeks, 3 months and 6 months
Stability of relative gingival margin position
Gingival margin position will be measured using Intra-oral digital Scan (IOS). It will be measured at baseline, immediately after surgery, 2 weeks, 3 months and 6 months. Scans will be superimposed to detect all changes throughout the follow up period.
Measured: Baseline, immediate postoperative, 2 weeks, 3 months and 6 months
Secondary outcomes (5)
Pink Esthetic Score by blinded assessment
It 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 is assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score.
Measured: At 3 months and 6 months
Postsurgical pain assessment
Readings will be recorded by the patient for the first 14 days after the surgery using the VAS which is a descriptive numerical rating scale of 0 to 10.
0 = No pain 1-3= Mild pain 4-6 = Moderate pain (bearable) 7-10 = Severe pain (unbearable)
Measured: At two weeks.
Patient satisfaction
A 3-item questionnaire will be given to the patients to be answered using a 7-point answer scale for assessing their satisfaction with the whole procedure and the results of the procedure performed.
Measured: Two weeks, three months and six months
Cost effectiveness
It will be calculated using an equation to correlate the procedural time, cost of the materials used against the clinical outcomes.
Measured: At six months.
Procedural Time
It will be recorded in minutes using a stopwatch to measure the difference in the procedural time between the two groups.
Measured: At the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start8 Oct 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jun 2026 (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
- Model description
- Randomized Clinical Trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Elganayni, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041541
- Sponsor's protocol ID
- Composite stops after ECL
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 6 Oct 2025
- 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 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Gingivalstat Approach Compared to Conventional Esthetic Crown Lengthening on the Stability of The Gingival Margin in Patients With Altered Passive Eruption. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07041541
- Acronym / sponsor ID
- Composite stops after ECL
- Keywords
- Gummy Smile, Altered Passive Eurption, Esthetic Crown Lengthening, GingivalStat Approach
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 27 Jun 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.
When performing crown lengthening surgery, especially in the esthetic zone, the positional stability of gingival tissues is considered a prime important goal. The rebound of gingival margins after surgery can result in compromising the esthetic outcome and patient satisfaction. It was proven throughout the literature that there are many factors that may influence the stability of gingival margin position after surgery such as: the surgical technique being performed, experience of the clinician, periodontal phenotype and distance of flap with respect to the alveolar crest.
Detailed description
A "gummy smile" or excessive gingival display (EGD) is when at least 3-5 mm of gingiva is visible. It is viewed as unnatural or unsightly, and in order to have the best outcome, cosmetic periodontal recontouring is frequently necessary. It is considered the treatment of choice for excessive gingival display, or "Gummy smile,". Many causes of gummy smiles have been found, including altered passive eruption, short upper lip, dentoalveolar extrusion, abnormal vertical bone growth, and a combination of some of these.
Altered passive eruption is when the gingival margin is located incisal to the cervical convexity of the crown and away from the cemento-enamel junction of the tooth. It is considered the most frequent related factor, accounting for between 12.1 and 35.8% of excessive gingival display cases that have been identified, according to evidence.
Considering esthetic crown lengthening (ECL) surgery, the goal is to restore the gingival harmony and symmetry by reestablishing the proper clinical crown length. However, stability of the periodontal tissues after ECL is a crucial aspect that can be jeopardized the treatment outcome of the treated region. In particular, gingival margin rebound can impair aesthetics and have an impact on the health of periodontal tissue
Predicting the amount of tissue rebound after esthetic crown lengthening surgery is still controversial. According to literature, there is a tendency to have a gingival regrowth from the immediate postoperative level for up to 3 months. It has been also confirmed that rebound of gingival margin most likely occurs during the first three months following surgery. Another study found that the gingival margin had coronal migration may continue for up to 6-12 months after surgery.
Based on current evidence, gingival margin rebound is a major issue that happens after performing crown lengthening surgery. To avoid this, GingivalStat approach has been proposed to guide the tissue after surgery to remodel early at a predetermined position and avoid the re-growth of gingiva in a coronal direction. It appears to be producing earlier stability. The current study aims to investigate the influence of GingivalStat following crown lengthening versus conventional crown lengthening, in terms of stability of gingival margin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Interventional group (Gingival Stat approach -- Composite stops after ECL surgery) | Experimental | Procedure: Esthetic Crown Lengthening using GingivalStat approachSteps 1-6 as Active Comparator group + 7. Resin composite wil be placed on the cervical third of the teeth, following the CEJ anatomy, to act as a gingival stabilizer to guide the early remodelling of tissues. 8. Removal of sutures and composite after two weeks. |
| Control group (Conventional ECL surgery) | Active comparator | Procedure: Esthetic Crown Lengthening1. Following the administration of local anaesthesia, a submarginal internal bevelled incision using 15c blade will be carried out, from canine to canine. The distance from the gingival margin will be based on how much soft tissue needs to be removed to meet the ideal tooth proportion. 2. Intrasulcular incision will be done in the buccal aspect and papilla region for removal of tissue collar. 3. A full thickness mucoperiosteal flap will be elevated using mucoperiosteal elevator, without bypassing the MGJ. 4. To obtain a 3 mm distance between CEJ and bone, osteoctomy wil be carried out from line angle to line angle using high speed hand piece with end-cutting bur. 5. Osteoplasty using round bur, maybe done to reduce bone thickness and obtain adequate anatomical profile. 6. After the flap is repositioned, interrupted sutures using Polypropylene 5-0 will be used to adapt and suture the flap in its new position. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with Altered Passive Eruption Subtype B presenting altered alveolar bone crest-CEJ relationship according to Coslet's et al. classification.
- Patients free of systemic diseases.
- Patients aged between 18 to 60 years old.
- Patients maintaining good oral hygiene with full-mouth plaque and bleeding scores <15%.
- Patients should be committed to the post-operative care regime, including oral hygiene practices, and follow-up visits.
Key exclusion criteria (5 listed)
- Areas in which the remaining amount of keratinized gingiva after the submarginal incision will be less than 3 mm.
- Patients with periodontal disease.
- Smokers.
- Pregnant women.
- Patients on medication that may interfere with healing (corticosteroids, bisphosphonate, Chemo/radiotherapy)
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 |
|---|---|---|
| Esthetic Crown LengtheningConventional Esthetic Crown Lengthening | Procedure or surgery | Control group (Conventional ECL surgery) |
| Esthetic Crown Lengthening using GingivalStat approachEsthetic Crown Lengthening using GingivalStat approach (composite stops) | Procedure or surgery | Interventional group (Gingival Stat approach -- Composite stops after ECL surgery) |
Primary outcome
Reduction in the gingival margin
Time frame: Baseline, immediate post operative, 2 weeks, 3 months and 6 months
Gingival margin position wil be measured using UNC periodontal probe + stent. Grooves will be made in the stent to standardize probe direction and localization. Each tooth will be assessed on the mesio-buccal, mid-buccal, and disto-buccal aspect at baseline, immediate post operative, 2 weeks, 3 months, and 6 months.
Stability of relative gingival margin position
Time frame: Baseline, immediate postoperative, 2 weeks, 3 months and 6 months
Gingival margin position will be measured using Intra-oral digital Scan (IOS). It will be measured at baseline, immediately after surgery, 2 weeks, 3 months and 6 months. Scans will be superimposed to detect all changes throughout the follow up period.
5 secondary outcomes
Pink Esthetic Score by blinded assessment
Time frame: At 3 months and 6 months
Postsurgical pain assessment
Time frame: At two weeks.
Patient satisfaction
Time frame: Two weeks, three months and six months
Cost effectiveness
Time frame: At six months.
Procedural Time
Time frame: At the surgery
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 6 Oct 2025.
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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 Esthetic Crown Lengthening and Esthetic Crown Lengthening using GingivalStat approach in people with Gummy Smile and Altered Passive Eruption of Teeth, run by Cairo 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 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 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?
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?
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?
Reduction in the gingival margin (time frame: Baseline, immediate post operative, 2 weeks, 3 months and 6 months). 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 6 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.