Gingival OvergrowthDIGICROWNNCT07575087
Comparison of Dual Digitally Guided vs Conventional Crown Lengthening
A study testing Conventional Crown Lengthening and Dual Digitally Guided Crown Lengthening in people with Gingival Overgrowth, run by Arab International University at 1 site in Syria.
Trial summary
This randomized controlled clinical trial aims to evaluate the clinical performance and patient-centered outcomes of dual digitally guided crown lengthening compared to the conventional surgical technique in the management of gummy smile caused by altered passive eruption (Type B1). Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Gingival Overgrowth
- What is being tested?
- Conventional Crown Lengthening and Dual Digitally Guided Crown Lengthening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSyria
- Study dates
- 1 Jul 2024to 25 Feb 2026
- 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients presenting with gummy smile due to altered passive eruption (Type B1)
- Presence of at least 6 maxillary anterior teeth indicated for crown lengthening
- Good oral hygiene and ability to maintain plaque control
- Systemically healthy patients
Who cannot join
- Poor oral hygiene
- Smokers
- Pregnancy or lactation
- Systemic diseases affecting periodontal tissues
- Previous periodontal surgery in the study area
- Active periodontal disease
Show all 9Show fewer
- Presence of periapical pathology in the study area
- Ongoing orthodontic treatment
- Gummy smile due to skeletal or muscular causes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Evaluating Digital Dual Surgical Guide in Esthetic Crown Lengthening
This randomized controlled clinical trial aims to evaluate the clinical performance and patient-centered outcomes of dual digitally guided crown lengthening compared to the conventional surgical technique in the management of gummy smile caused by altered passive eruption (Type B1).
A total of 18 patients will be randomly allocated into two groups: the control group will undergo conventional crown lengthening based on clinical measurements, while the intervention group will receive crown lengthening using a dual digitally fabricated surgical guide.
Read more
The primary outcome is the gain in clinical crown length at 3 months. Secondary outcomes include operating time, pain perception, patient satisfaction, gingival margin stability, and periodontal clinical parameters.
This study aims to determine whether digital guidance improves surgical accuracy, efficiency, and patient satisfaction compared to traditional techniques
Read the detailed description
Esthetic crown lengthening is a commonly performed periodontal surgical procedure indicated for the correction of excessive gingival display, particularly in cases of altered passive eruption. Achieving optimal esthetic outcomes requires precise determination of gingival and osseous resection levels, which can be challenging using conventional clinical methods.
With the advancement of digital dentistry, computer-aided design and manufacturing (CAD/CAM) technologies have enabled the development of digitally guided surgical approaches. The dual digitally guided technique integrates two levels of guidance to control both soft tissue and bone resection, potentially enhancing surgical precision and predictability.
This randomized controlled clinical trial is designed to compare the effectiveness of dual digitally guided crown lengthening with the conventional technique in patients presenting with gummy smile due to altered passive eruption (Type B1).
Eighteen systemically healthy patients aged 18-40 years will be recruited and randomly assigned into two equal groups. The control group will undergo conventional crown lengthening using clinical measurements and manual surgical techniques. The intervention group will be treated using a dual digitally fabricated surgical guide based on digital smile design, CBCT analysis, and intraoral scanning.
Clinical and patient-reported outcomes will be assessed at baseline and during follow-up periods. The primary outcome is the gain in clinical crown length measured at 3 months postoperatively. Secondary outcomes include operating time, pain (VAS), patient satisfaction (VAS), gingival margin level, probing depth, gingival index, plaque index, bleeding on probing, keratinized gingival height, and gingival thickness.
The results of this study are expected to provide evidence regarding the benefits of digital guidance in periodontal esthetic surgery and its potential to improve clinical outcomes and patient experience.
- Conditions
- Gingival Overgrowth
- Being tested
- Conventional Crown Lengthening, Dual Digitally Guided Crown Lengthening
- Keywords
- Crown Lengthening, Digital Surgical Guide, Guided Surgery
- Medical subject headings
- Gingival Overgrowth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Crown LengtheningProcedure or surgery
Conventional surgical crown lengthening performed based on clinical examination and manual measurements. The procedure includes gingival recontouring and osseous resection carried out according to standard periodontal surgical protocols without the use of digital guidance.
Dual Digitally Guided Crown LengtheningProcedure or surgery
Crown lengthening performed using a dual digitally fabricated surgical guide. The procedure is planned using digital smile design, intraoral scanning, and CBCT imaging to guide both soft tissue and bone resection, enhancing surgical accuracy and predictability.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Crown Lengthening | Active comparator | Participants in this group will undergo conventional surgical crown lengthening based on clinical evaluation and manual measurements. The procedure includes gingivectomy and osseous resection performed according to standard periodontal surgical protocols without the use of digital guidance. Receives: Procedure: Conventional Crown Lengthening |
| Dual Digitally Guided Crown Lengthening | Experimental | Participants in this group will receive crown lengthening using a dual digitally fabricated surgical guide. The procedure is planned using digital smile design, intraoral scanning, and CBCT analysis to guide both soft tissue and bone resection, aiming to improve surgical precision and predictability. Receives: Procedure: Dual Digitally Guided Crown Lengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gain in Clinical Crown Length
Change in clinical crown length (mm), measured from the incisal edge to the gingival margin using a periodontal probe, to assess the effectiveness of crown lengthening procedures.
Measured: Baseline and 3 months postoperatively
Secondary outcomes (10)
Surgical Operating Time
Total duration of the surgical procedure measured in minutes from the first incision to completion of osteotomy.
Measured: During surgery (intraoperative)
Postoperative Pain (Visual Analog Scale)
Patient-reported pain assessed using a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Measured: 24 hours, 7 days, and 14 days postoperatively
Patient Satisfaction (Visual Analog Scale)
Patient satisfaction with the esthetic and functional outcome measured using a Visual Analogue Scale (VAS).
Measured: 7 days and 3 months postoperatively
Relative Gingival Margin Level
Measurement of gingival margin position (mm) relative to a fixed reference point to evaluate soft tissue stability.
Measured: Baseline, 1 week, and 3 months postoperatively
Probing Depth
Periodontal probing depth (mm) measured at standardized sites using a periodontal probe.
Measured: Baseline and 3 months postoperatively
Gingival Index (GI)
Assessment of gingival inflammation using the Gingival Index scoring system.
Measured: Baseline and 3 months postoperatively
Plaque Index (PI)
Assessment of oral hygiene status using the Plaque Index scoring system.
Measured: Baseline and 3 months postoperatively
Bleeding on Probing (BOP)
Presence or absence of bleeding upon gentle probing, expressed as a percentage of bleeding sites.
Measured: Baseline and 3 months postoperatively
Keratinized Gingival Height
Width of keratinized gingiva (mm) measured from the gingival margin to the mucogingival junction.
Measured: Baseline, 1 week, and 3 months postoperatively
Gingival Thickness
Thickness of gingival tissue (mm) measured using transgingival probing or ultrasound methods.
Measured: Baseline and 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Jul 2024
- Primary completion15 Oct 2025
- Study completion25 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gingival OvergrowthStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arab International University
- Sponsor type
- University, hospital or other
- Collaborators
- Damascus University
- Responsible party
- Sponsor
- Investigators
- Raghad Alrefaai, DDs, Principal investigator, Damascus UniversityRazan Khattab, PhD, Study chair, Damascus UniversitySaleh Al Kurdi, PhD, Study director, Arab International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575087
- Sponsor's protocol ID
- DN-10062024-3764
- Acronym
- DIGICROWN
- Status last verified
- Sep 2026
- First submitted
- 4 May 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pavone AF, Ghassemian M, Verardi S. Gummy Smile and Short Tooth Syndrome--Part 1: Etiopathogenesis, Classification, and Diagnostic Guidelines. Compend Contin Educ Dent. 2016 Feb;37(2):102-7; quiz 108-10.
PubMed 26905089Marzadori M, Stefanini M, Sangiorgi M, Mounssif I, Monaco C, Zucchelli G. Crown lengthening and restorative procedures in the esthetic zone. Periodontol 2000. 2018 Jun;77(1):84-92. doi: 10.1111/prd.12208. Epub 2018 Mar 1.
PubMed 29493814Malkinson S, Waldrop TC, Gunsolley JC, Lanning SK, Sabatini R. The effect of esthetic crown lengthening on perceptions of a patient's attractiveness, friendliness, trustworthiness, intelligence, and self-confidence. J Periodontol. 2013 Aug;84(8):1126-33. doi: 10.1902/jop.2012.120403. Epub 2012 Nov 9.
PubMed 23137007Bynum J. Treatment of a "Gummy Smile": Understanding Etiology is Key to Success. Compend Contin Educ Dent. 2016 Feb;37(2):114-22.
PubMed 26905090Carrera TMI, Freire AEN, de Oliveira GJPL, Dos Reis Nicolau S, Pichotano EC, Junior NVR, Pires LC, Pigossi SC. Digital planning and guided dual technique in esthetic crown lengthening: a randomized controlled clinical trial. Clin Oral Investig. 2023 Apr;27(4):1589-1603. doi: 10.1007/s00784-022-04780-8. Epub 2022 Nov 21.
PubMed 36409356
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Evaluating Digital Dual Surgical Guide in Esthetic Crown Lengthening
- ClinicalTrials.gov ID
- NCT07575087
- Acronym / sponsor ID
- DIGICROWN / DN-10062024-3764
- Conditions
- Gingival Overgrowth
- Keywords
- Crown Lengthening, Digital Surgical Guide, Guided Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Arab International UniversityUniversity, hospital or other
- Collaborators
- Damascus University
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 8 May 2026 (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.
This randomized controlled clinical trial aims to evaluate the clinical performance and patient-centered outcomes of dual digitally guided crown lengthening compared to the conventional surgical technique in the management of gummy smile caused by altered passive eruption (Type B1).
A total of 18 patients will be randomly allocated into two groups: the control group will undergo conventional crown lengthening based on clinical measurements, while the intervention group will receive crown lengthening using a dual digitally fabricated surgical guide.
The primary outcome is the gain in clinical crown length at 3 months. Secondary outcomes include operating time, pain perception, patient satisfaction, gingival margin stability, and periodontal clinical parameters.
This study aims to determine whether digital guidance improves surgical accuracy, efficiency, and patient satisfaction compared to traditional techniques
Detailed description
Esthetic crown lengthening is a commonly performed periodontal surgical procedure indicated for the correction of excessive gingival display, particularly in cases of altered passive eruption. Achieving optimal esthetic outcomes requires precise determination of gingival and osseous resection levels, which can be challenging using conventional clinical methods.
With the advancement of digital dentistry, computer-aided design and manufacturing (CAD/CAM) technologies have enabled the development of digitally guided surgical approaches. The dual digitally guided technique integrates two levels of guidance to control both soft tissue and bone resection, potentially enhancing surgical precision and predictability.
This randomized controlled clinical trial is designed to compare the effectiveness of dual digitally guided crown lengthening with the conventional technique in patients presenting with gummy smile due to altered passive eruption (Type B1).
Eighteen systemically healthy patients aged 18-40 years will be recruited and randomly assigned into two equal groups. The control group will undergo conventional crown lengthening using clinical measurements and manual surgical techniques. The intervention group will be treated using a dual digitally fabricated surgical guide based on digital smile design, CBCT analysis, and intraoral scanning.
Clinical and patient-reported outcomes will be assessed at baseline and during follow-up periods. The primary outcome is the gain in clinical crown length measured at 3 months postoperatively. Secondary outcomes include operating time, pain (VAS), patient satisfaction (VAS), gingival margin level, probing depth, gingival index, plaque index, bleeding on probing, keratinized gingival height, and gingival thickness.
The results of this study are expected to provide evidence regarding the benefits of digital guidance in periodontal esthetic surgery and its potential to improve clinical outcomes and patient experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Crown Lengthening | Active comparator | Procedure: Conventional Crown LengtheningParticipants in this group will undergo conventional surgical crown lengthening based on clinical evaluation and manual measurements. The procedure includes gingivectomy and osseous resection performed according to standard periodontal surgical protocols without the use of digital guidance. |
| Dual Digitally Guided Crown Lengthening | Experimental | Procedure: Dual Digitally Guided Crown LengtheningParticipants in this group will receive crown lengthening using a dual digitally fabricated surgical guide. The procedure is planned using digital smile design, intraoral scanning, and CBCT analysis to guide both soft tissue and bone resection, aiming to improve surgical precision and predictability. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients presenting with gummy smile due to altered passive eruption (Type B1)
- Presence of at least 6 maxillary anterior teeth indicated for crown lengthening
- Good oral hygiene and ability to maintain plaque control
- Systemically healthy patients
Key exclusion criteria (9 listed)
- Poor oral hygiene
- Smokers
- Pregnancy or lactation
- Systemic diseases affecting periodontal tissues
- Previous periodontal surgery in the study area
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 Crown LengtheningConventional surgical crown lengthening performed based on clinical examination and manual measurements. The procedure includes gingival recontouring and osseous resection carried out according to standard periodontal surgical protocols without the use of digital guidance. | Procedure or surgery | Conventional Crown Lengthening |
| Dual Digitally Guided Crown LengtheningCrown lengthening performed using a dual digitally fabricated surgical guide. The procedure is planned using digital smile design, intraoral scanning, and CBCT imaging to guide both soft tissue and bone resection, enhancing surgical accuracy and predictability. | Procedure or surgery | Dual Digitally Guided Crown Lengthening |
Primary outcome
Gain in Clinical Crown Length
Time frame: Baseline and 3 months postoperatively
Change in clinical crown length (mm), measured from the incisal edge to the gingival margin using a periodontal probe, to assess the effectiveness of crown lengthening procedures.
10 secondary outcomes
Surgical Operating Time
Time frame: During surgery (intraoperative)
Postoperative Pain (Visual Analog Scale)
Time frame: 24 hours, 7 days, and 14 days postoperatively
Patient Satisfaction (Visual Analog Scale)
Time frame: 7 days and 3 months postoperatively
Relative Gingival Margin Level
Time frame: Baseline, 1 week, and 3 months postoperatively
Probing Depth
Time frame: Baseline and 3 months postoperatively
Gingival Index (GI)
Time frame: Baseline and 3 months postoperatively
Plaque Index (PI)
Time frame: Baseline and 3 months postoperatively
Bleeding on Probing (BOP)
Time frame: Baseline and 3 months postoperatively
Keratinized Gingival Height
Time frame: Baseline, 1 week, and 3 months postoperatively
Gingival Thickness
Time frame: Baseline and 3 months postoperatively
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 4 Sep 2026.
- Background: PubMed 26905089Pavone AF, Ghassemian M, Verardi S. Gummy Smile and Short Tooth Syndrome--Part 1: Etiopathogenesis, Classification, and Diagnostic Guidelines. Compend Contin Educ Dent. 2016 Feb;37(2):102-7; quiz 108-10.
- Background: PubMed 29493814Marzadori M, Stefanini M, Sangiorgi M, Mounssif I, Monaco C, Zucchelli G. Crown lengthening and restorative procedures in the esthetic zone. Periodontol 2000. 2018 Jun;77(1):84-92. doi: 10.1111/prd.12208. Epub 2018 Mar 1.
- Background: PubMed 23137007Malkinson S, Waldrop TC, Gunsolley JC, Lanning SK, Sabatini R. The effect of esthetic crown lengthening on perceptions of a patient's attractiveness, friendliness, trustworthiness, intelligence, and self-confidence. J Periodontol. 2013 Aug;84(8):1126-33. doi: 10.1902/jop.2012.120403. Epub 2012 Nov 9.
- Background: PubMed 26905090Bynum J. Treatment of a "Gummy Smile": Understanding Etiology is Key to Success. Compend Contin Educ Dent. 2016 Feb;37(2):114-22.
- Background: PubMed 36409356Carrera TMI, Freire AEN, de Oliveira GJPL, Dos Reis Nicolau S, Pichotano EC, Junior NVR, Pires LC, Pigossi SC. Digital planning and guided dual technique in esthetic crown lengthening: a randomized controlled clinical trial. Clin Oral Investig. 2023 Apr;27(4):1589-1603. doi: 10.1007/s00784-022-04780-8. Epub 2022 Nov 21.
- Individual participant dataSharing planned: No
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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.
Raghad Alrefaai, DDs principal investigator
Damascus University
Razan Khattab, PhD study chair
Damascus University
Saleh Al Kurdi, PhD study director
Arab International 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 Conventional Crown Lengthening and Dual Digitally Guided Crown Lengthening in people with Gingival Overgrowth, run by Arab International University at 1 site in Syria.
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 9 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 4 Sep 2026. 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 Syria. 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?
Gain in Clinical Crown Length (time frame: Baseline and 3 months postoperatively). 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 NCT07575087, which also lists 5 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 4 Sep 2026.