Gummy SmileNCT06801548
Fully Digital Guided Esthetic Crown Lengthening Surgery
A study testing Esthetic crown lengthening surgery and Esthetic crown lengthening surgery using Digital guide in people with Gummy Smile, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this randomized controlled clinical study is to compare Fully digital to wax-up/mock-up guided esthetic crown lengthening procedure in management of excessive gingival display caused by altered passive eruption type 1B The main question it aims to answer is: Does the fully digital guided gingivectomy… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Gummy Smile
- What is being tested?
- Esthetic crown lengthening surgery and Esthetic crown lengthening surgery using Digital guide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2025to 20 May 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who have Altered passive eruption (APE) type 1 B, according to classification of APE by Coslet et al.
- Both genders aged from 20-50 years. Patients have thick gingival phenotype (thickness of gingiva is ≥ 1 mm) Patients should be systematically free from any disease.
Who cannot join
- Pregnant and lactating females.
- Heavy smoker ≥ 10 cigarettes/day.
- Poor oral hygiene.
- Patients with occlusal or malalignment problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fully Digital Guided Esthetic Crown Lengthening Surgery: Evaluation of Accuracy and Patient Satisfaction (A Randomized Controlled Clinical Study)
The goal of this randomized controlled clinical study is to compare Fully digital to wax-up/mock-up guided esthetic crown lengthening procedure in management of excessive gingival display caused by altered passive eruption type 1B
The main question it aims to answer is:
Does the fully digital guided gingivectomy approach able to introduce a more precise, accuracy and reliability technique with more patient satisfaction compared to the mock-up guided method?
Read the detailed description
In today's world, the idea of smile and dental aesthetics extends beyond just the teeth. The fundamentals of a smile center on the interaction between the three key elements: the teeth, lips , and the gingiva.
Gummy smile (Excessive gingival display) is acknowledged by the American Academy of Periodontology (AAP) as a deformity and mucogingival problem that impacts the area surrounding the teeth
This condition may result from various etiological factors: short lip, hypermobile/hyperactive lip, short clinical crowns, dentoalveolar extrusion, altered passive eruption (APE), gingival hyperplasia, and vertical maxillary excess.
Altered passive eruption is described as "the gingival margin in adults is positioned incisal to the crown's cervical convexity and distanced from the tooth's cementoenamel junction."
Altered passive eruption defined as "the gingival margin in the adult is located incisal to the cervical convexity of the crown and removed from the cementoenamel junction of the tooth".
Altered passive eruption classified into two main classes according to the relationship of the gingiva to the anatomic crown and furthermore subdivided those classes according to the position of the osseous crest. The two types are subdivided into four categories: 1A, 1B and 2A, 2B.
The diagnosis of APE is made on a collective clinical and radiographic examination, it begins with analyzing the repose during a natural smile followed by analyzing the gingival display, the alveolar crest level, as well as the lip line of the patient.
Determination can be made whether a gingivectomy alone will suffice or a gingival flap will be needed with or without ostectomy will depend of the diagnosis of APE and classification of each case.
The selection of one technique over another depends on several patient related factors such as esthetics, clinical crown to root ratio, root proximity, root morphology, furcation location, individual tooth position, collective tooth position and ability to restore the teeth.
Esthetic crown lengthening (ECL) approach (both gingivectomy and bone removal) is used when less than 2 mm exists between the crest of the bone and the new gingival margin, and an adequate attached gingiva will remain after surgery (APE type IB).
Diagnostic mock-up fabricated using a temporary bis-acrylic resin with a putty guide directly from the wax-up can be used to provide the patient and clinician with an evaluation of the future outcome and can be used as a surgical guide for crown lengthening procedures.
The major limitations with wax-up/ mock-up guided esthetic crown lengthening procedure would be the time consumed during making and modifying conventional wax-ups as well as the unpredictable estimate of where the gingival margin should be.
Utilization of digital workflows allowed the enhancement of communication and might improve the predictability of contemporary ECL approach.
The introduction of computer-aided design and computer-aided manufacturing (CAD-CAM) techniques has helped surgeons perform more precise and predictable surgery and contributed to improved esthetics.
By combining the use of Digital Smile Design and CAD/CAM technology with (3D) printing, a surgical guide for ECL procedure could be produced.
The aim of the present study will be to evaluate accuracy and reliability of digital guided method of ECL procedure using CAD CAM technology versus conventional method using resin Mock-up as ECL surgical guide.
- Conditions
- Gummy Smile
- Being tested
- Esthetic crown lengthening surgery, Esthetic crown lengthening surgery using Digital guide
- Keywords
- Esthetic crown lengthening, Gingivectomy, Guided surgery, Wax-up, Digital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esthetic crown lengthening surgeryProcedure or surgery
Esthetic crown lengthening surgery using mock-up based guide
Esthetic crown lengthening surgery using Digital guideProcedure or surgery
Esthetic crown lengthening surgery using digital guide based on DSD and CBCT
| Study group | Role | What they receive |
|---|---|---|
| Conventional arm | Active comparator | Esthetic crown lengthening surgery is done using mock-up based guide Receives: Procedure: Esthetic crown lengthening surgery |
| Digital arm | Active comparator | Esthetic crown lengthening surgery is done using digital guide Receives: Procedure: Esthetic crown lengthening surgery using Digital guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of both guides
The accuracy can be measured by comparing the planned surgery and the actual result of the surgery Linear measurement in millimeters
Measured: Immediately after the surgery
Secondary outcomes (2)
Patient satisfaction
This can be measured using a questionnaire includes questions about patient expectations about the surgery, pain during and after the surgery, and the overall results
Measured: 3 months after the surgery
Marginal stability
Gingival margin is been evaluated after 4 weeks and 3 months of the surgery using subsequent intraoral scanning Linear measurement in millimeters
Measured: 4 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start20 Feb 2025 (estimated)
- Primary completion15 Mar 2025 (estimated)
- Study completion20 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Gummy SmileStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Abdelnabi, Ain Shams University
- Investigators
- Ahmed E Amr, Ass.Prof, Study director, Faculty of Dentistry - Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801548
- Sponsor's protocol ID
- FDASU-ReclM122210
- Status last verified
- Mar 2024
- First submitted
- 25 Jan 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vercruyssen M, Cox C, Coucke W, Naert I, Jacobs R, Quirynen M. A randomized clinical trial comparing guided implant surgery (bone- or mucosa-supported) with mental navigation or the use of a pilot-drill template. J Clin Periodontol. 2014 Jul;41(7):717-23. doi: 10.1111/jcpe.12231. Epub 2014 Apr 10.
PubMed 24460748Lee EA. Aesthetic crown lengthening: classification, biologic rationale, and treatment planning considerations. Pract Proced Aesthet Dent. 2004 Nov-Dec;16(10):769-78; quiz 780.
PubMed 15739921Ganji KK, Patil VA, John J. A Comparative Evaluation for Biologic Width following Surgical Crown Lengthening Using Gingivectomy and Ostectomy Procedure. Int J Dent. 2012;2012:479241. doi: 10.1155/2012/479241. Epub 2012 Aug 26.
PubMed 22969804Jepsen S, Caton JG, Albandar JM, Bissada NF, Bouchard P, Cortellini P, Demirel K, de Sanctis M, Ercoli C, Fan J, Geurs NC, Hughes FJ, Jin L, Kantarci A, Lalla E, Madianos PN, Matthews D, McGuire MK, Mills MP, Preshaw PM, Reynolds MA, Sculean A, Susin C, West NX, Yamazaki K. Periodontal manifestations of systemic diseases and developmental and acquired conditions: Consensus report of workgroup 3 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S237-S248. doi: 10.1002/JPER.17-0733.
PubMed 29926943Shobha KS, Mahantesha, Seshan H, Mani R, Kranti K. Clinical evaluation of the biological width following surgical crown-lengthening procedure: A prospective study. J Indian Soc Periodontol. 2010 Jul;14(3):160-7. doi: 10.4103/0972-124X.75910.
PubMed 21760669Nugala B, Kumar BS, Sahitya S, Krishna PM. Biologic width and its importance in periodontal and restorative dentistry. J Conserv Dent. 2012 Jan;15(1):12-7. doi: 10.4103/0972-0707.92599.
PubMed 22368328Liu X, Yu J, Zhou J, Tan J. A digitally guided dual technique for both gingival and bone resection during crown lengthening surgery. J Prosthet Dent. 2018 Mar;119(3):345-349. doi: 10.1016/j.prosdent.2017.04.018. Epub 2017 Jul 8.
PubMed 28689907Garber DA, Salama MA. The aesthetic smile: diagnosis and treatment. Periodontol 2000. 1996 Jun;11:18-28. doi: 10.1111/j.1600-0757.1996.tb00179.x. No abstract available.
PubMed 9567953Coslet JG, Vanarsdall R, Weisgold A. Diagnosis and classification of delayed passive eruption of the dentogingival junction in the adult. Alpha Omegan. 1977 Dec;70(3):24-8. No abstract available.
PubMed 276255Bhola M, Fairbairn PJ, Kolhatkar S, Chu SJ, Morris T, de Campos M. LipStaT: The Lip Stabilization Technique- Indications and Guidelines for Case Selection and Classification of Excessive Gingival Display. Int J Periodontics Restorative Dent. 2015 Jul-Aug;35(4):549-59. doi: 10.11607/prd.2059.
PubMed 26133145
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fully Digital Guided Esthetic Crown Lengthening Surgery: Evaluation of Accuracy and Patient Satisfaction (A Randomized Controlled Clinical Study)
- ClinicalTrials.gov ID
- NCT06801548
- Acronym / sponsor ID
- FDASU-ReclM122210
- Conditions
- Gummy Smile
- Keywords
- Esthetic crown lengthening, Gingivectomy, Guided surgery, Wax-up, Digital
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Feb 2025 (estimated)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 20 May 2025 (estimated)
- First posted
- 30 Jan 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.
The goal of this randomized controlled clinical study is to compare Fully digital to wax-up/mock-up guided esthetic crown lengthening procedure in management of excessive gingival display caused by altered passive eruption type 1B
The main question it aims to answer is:
Does the fully digital guided gingivectomy approach able to introduce a more precise, accuracy and reliability technique with more patient satisfaction compared to the mock-up guided method?
Detailed description
In today's world, the idea of smile and dental aesthetics extends beyond just the teeth. The fundamentals of a smile center on the interaction between the three key elements: the teeth, lips , and the gingiva.
Gummy smile (Excessive gingival display) is acknowledged by the American Academy of Periodontology (AAP) as a deformity and mucogingival problem that impacts the area surrounding the teeth
This condition may result from various etiological factors: short lip, hypermobile/hyperactive lip, short clinical crowns, dentoalveolar extrusion, altered passive eruption (APE), gingival hyperplasia, and vertical maxillary excess.
Altered passive eruption is described as "the gingival margin in adults is positioned incisal to the crown's cervical convexity and distanced from the tooth's cementoenamel junction."
Altered passive eruption defined as "the gingival margin in the adult is located incisal to the cervical convexity of the crown and removed from the cementoenamel junction of the tooth".
Altered passive eruption classified into two main classes according to the relationship of the gingiva to the anatomic crown and furthermore subdivided those classes according to the position of the osseous crest. The two types are subdivided into four categories: 1A, 1B and 2A, 2B.
The diagnosis of APE is made on a collective clinical and radiographic examination, it begins with analyzing the repose during a natural smile followed by analyzing the gingival display, the alveolar crest level, as well as the lip line of the patient.
Determination can be made whether a gingivectomy alone will suffice or a gingival flap will be needed with or without ostectomy will depend of the diagnosis of APE and classification of each case.
The selection of one technique over another depends on several patient related factors such as esthetics, clinical crown to root ratio, root proximity, root morphology, furcation location, individual tooth position, collective tooth position and ability to restore the teeth.
Esthetic crown lengthening (ECL) approach (both gingivectomy and bone removal) is used when less than 2 mm exists between the crest of the bone and the new gingival margin, and an adequate attached gingiva will remain after surgery (APE type IB).
Diagnostic mock-up fabricated using a temporary bis-acrylic resin with a putty guide directly from the wax-up can be used to provide the patient and clinician with an evaluation of the future outcome and can be used as a surgical guide for crown lengthening procedures.
The major limitations with wax-up/ mock-up guided esthetic crown lengthening procedure would be the time consumed during making and modifying conventional wax-ups as well as the unpredictable estimate of where the gingival margin should be.
Utilization of digital workflows allowed the enhancement of communication and might improve the predictability of contemporary ECL approach.
The introduction of computer-aided design and computer-aided manufacturing (CAD-CAM) techniques has helped surgeons perform more precise and predictable surgery and contributed to improved esthetics.
By combining the use of Digital Smile Design and CAD/CAM technology with (3D) printing, a surgical guide for ECL procedure could be produced.
The aim of the present study will be to evaluate accuracy and reliability of digital guided method of ECL procedure using CAD CAM technology versus conventional method using resin Mock-up as ECL surgical guide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional arm | Active comparator | Procedure: Esthetic crown lengthening surgeryEsthetic crown lengthening surgery is done using mock-up based guide |
| Digital arm | Active comparator | Procedure: Esthetic crown lengthening surgery using Digital guideEsthetic crown lengthening surgery is done using digital guide |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients who have Altered passive eruption (APE) type 1 B, according to classification of APE by Coslet et al.
- Both genders aged from 20-50 years. Patients have thick gingival phenotype (thickness of gingiva is ≥ 1 mm) Patients should be systematically free from any disease.
Key exclusion criteria (4 listed)
- Pregnant and lactating females.
- Heavy smoker ≥ 10 cigarettes/day.
- Poor oral hygiene.
- Patients with occlusal or malalignment problems.
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 lengthening surgeryEsthetic crown lengthening surgery using mock-up based guide | Procedure or surgery | Conventional arm |
| Esthetic crown lengthening surgery using Digital guideEsthetic crown lengthening surgery using digital guide based on DSD and CBCT | Procedure or surgery | Digital arm |
Primary outcome
Accuracy of both guides
Time frame: Immediately after the surgery
The accuracy can be measured by comparing the planned surgery and the actual result of the surgery Linear measurement in millimeters
2 secondary outcomes
Patient satisfaction
Time frame: 3 months after the surgery
Marginal stability
Time frame: 4 weeks and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Results publication: PubMed 24460748Vercruyssen M, Cox C, Coucke W, Naert I, Jacobs R, Quirynen M. A randomized clinical trial comparing guided implant surgery (bone- or mucosa-supported) with mental navigation or the use of a pilot-drill template. J Clin Periodontol. 2014 Jul;41(7):717-23. doi: 10.1111/jcpe.12231. Epub 2014 Apr 10.
- Results publication: PubMed 15739921Lee EA. Aesthetic crown lengthening: classification, biologic rationale, and treatment planning considerations. Pract Proced Aesthet Dent. 2004 Nov-Dec;16(10):769-78; quiz 780.
- Results publication: PubMed 22969804Ganji KK, Patil VA, John J. A Comparative Evaluation for Biologic Width following Surgical Crown Lengthening Using Gingivectomy and Ostectomy Procedure. Int J Dent. 2012;2012:479241. doi: 10.1155/2012/479241. Epub 2012 Aug 26.
- Results publication: PubMed 29926943Jepsen S, Caton JG, Albandar JM, Bissada NF, Bouchard P, Cortellini P, Demirel K, de Sanctis M, Ercoli C, Fan J, Geurs NC, Hughes FJ, Jin L, Kantarci A, Lalla E, Madianos PN, Matthews D, McGuire MK, Mills MP, Preshaw PM, Reynolds MA, Sculean A, Susin C, West NX, Yamazaki K. Periodontal manifestations of systemic diseases and developmental and acquired conditions: Consensus report of workgroup 3 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S237-S248. doi: 10.1002/JPER.17-0733.
- Results publication: PubMed 21760669Shobha KS, Mahantesha, Seshan H, Mani R, Kranti K. Clinical evaluation of the biological width following surgical crown-lengthening procedure: A prospective study. J Indian Soc Periodontol. 2010 Jul;14(3):160-7. doi: 10.4103/0972-124X.75910.
- Results publication: PubMed 22368328Nugala B, Kumar BS, Sahitya S, Krishna PM. Biologic width and its importance in periodontal and restorative dentistry. J Conserv Dent. 2012 Jan;15(1):12-7. doi: 10.4103/0972-0707.92599.
- Results publication: PubMed 28689907Liu X, Yu J, Zhou J, Tan J. A digitally guided dual technique for both gingival and bone resection during crown lengthening surgery. J Prosthet Dent. 2018 Mar;119(3):345-349. doi: 10.1016/j.prosdent.2017.04.018. Epub 2017 Jul 8.
- Results publication: PubMed 9567953Garber DA, Salama MA. The aesthetic smile: diagnosis and treatment. Periodontol 2000. 1996 Jun;11:18-28. doi: 10.1111/j.1600-0757.1996.tb00179.x. No abstract available.
- Results publication: PubMed 276255Coslet JG, Vanarsdall R, Weisgold A. Diagnosis and classification of delayed passive eruption of the dentogingival junction in the adult. Alpha Omegan. 1977 Dec;70(3):24-8. No abstract available.
- Results publication: PubMed 26133145Bhola M, Fairbairn PJ, Kolhatkar S, Chu SJ, Morris T, de Campos M. LipStaT: The Lip Stabilization Technique- Indications and Guidelines for Case Selection and Classification of Excessive Gingival Display. Int J Periodontics Restorative Dent. 2015 Jul-Aug;35(4):549-59. doi: 10.11607/prd.2059.
- 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.
Ahmed E Amr, Ass.Prof study director
Faculty of Dentistry - Ain Shams 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 Esthetic crown lengthening surgery and Esthetic crown lengthening surgery using Digital guide in people with Gummy Smile, 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 2 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 25 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdallah A. Aref, Master student (00201111711467, abdallah.aref.std@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of both guides (time frame: Immediately after the surgery). 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 NCT06801548, which also lists 10 linked publications.
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 25 Feb 2025.