AzTrials
AzTrials

Altered Passive Eruption of TeethNCT05969132

Digital Versus Conventional Guided Gingivectomy

A study testing Fully digital guided gingivectomy procedure and Convectional guided gingivectomy procedure in people with Altered Passive Eruption of Teeth, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The goal of this randomized controlled clinical study is to compare Fully digital to conventional guided Gingivectomy procedure in management of excessive gingival display caused by altered passive eruption type 1A. 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
What is being tested?
Fully digital guided gingivectomy procedure and Convectional guided gingivectomy procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteEgypt
Study dates
31 Dec 2024to 1 May 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 20 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Patients complaining of Excessive gingival display (3mm or more gingival display at full smiling)
  • Patients classified as Altered Passive Eruption Type 1A

Who cannot join

  • Patients need restorative or orthodontic correction.
  • Pregnant and lactating females.
  • Heavy smoker ≥ 10 cigarettes/day.
  • Poor oral hygiene.
  • Patients with systemic diseases which could influence the outcome of the therapy e.g.
  • (Diabetic patients).
  • Heavy smoker ≥ 10 cigarettes/day.
  • Vulnerable groups of patients e.g. (prisoners, handicapped patients and decisionally impaired individuals)

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Fentistry Ain Shams university

    Cairo, 11566

Other trials in Egypt

About this study

Official title: Fully Digital Guided Gingivectomy in Management of Gummy Smile: Evaluation of Accuracy and Patient Satisfaction

The goal of this randomized controlled clinical study is to compare Fully digital to conventional guided Gingivectomy procedure in management of excessive gingival display caused by altered passive eruption type 1A.

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 conventional guided method?

Read the detailed description

Nowadays, the concept of smile and dental esthetics is no longer limited to the teeth. The essentials of a smile involve the relationship between the three primary components: the teeth, lip framework, and the gingival scaffold.

The term "pink aesthetics" refers to the aesthetics of gingival tissues, which play a significant influence in smile aesthetics.

Excessive gingival display while smiling, also usually known as a "gummy smile," is a common esthetic concern among dental patients and, being largely viewed as unesthetic, leads many patients to seek some form of treatment to address the issue.

Gummy smile (Excessive gingival display) is recognized by the American Academy of Periodontology (AAP) as a deformity and mucogingival condition that affects the area around the teeth.

This condition could be caused by many 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 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.

The gingivectomy approach alone is used when 3 mm gingival tissue or greater exists from bone to gingival crest, and an adequate attached gingiva will remain after surgery (APE type IA).

A diagnostic wax-up then an intraoral fabricated mock-up representing the desired outcome can assist in the selection of proper planning of the need for periodontal surgical approach.

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 gingivectomy procedures.

The major limitations with conventional guided gingivectomy 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 gingivectomy 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 Gingivectomy procedure could be produced.

The aim of the present study will be to evaluate accuracy and reliability of digital guided method of gingivectomy procedure using CAD CAM technology versus conventional method using resin Mock-up as gingivectomy surgical guide.

Research Question "Does the fully digital guided gingivectomy approach able to introduce a more precise, accuracy and reliability technique with more patient satisfaction compared to the conventional guided method?"

Being tested
Fully digital guided gingivectomy procedure, Convectional guided gingivectomy procedure
Keywords
gummy smile, excessive gingival display, Altered Passive Eruption, gingivectomy, fully digital guided

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fully digital guided gingivectomy procedureProcedure or surgery

    1. Full history with clinical and radiographic examination (CBCT) to aid in patient's selection.
    2. Supra- and sub-gingival debridement.
    3. Oral hygiene instructions (OHI)
    4. Presurgical intraoral scanning using an intraoral scanner (IOS)
    5. Fabrication of the Gingivectomy guide:
    • Convert (DICOM) file to STL file then merged to STL file corresponding oral soft tissues 3D data obtained by IOS using software of surgical planning.
    • Digital waxing up with new desired positions of gingival margins and zenith points performed.
    • Designing Gingivectomy guide then exported to a 3D printer and mill a transparent resin gingivectomy guide.
    1. Surgical Procedure: anesthetized the patient using local anesthesia, Surgical incision using 15c blade following CEJ anatomy will be made at each tooth using the Gingivectomy guide as reference to new gingival level and being careful to preserve the gingival papillae without involving the palatal surfaces.
    2. Postoperative care
  • Convectional guided gingivectomy procedureProcedure or surgery

    1. Full history with clinical and radiographic examination (CBCT) to aid in patient's selection.
    2. Supra- and sub-gingival debridement with OHI
    3. Gingivectomy guide fabrication:
    • Impressions and casts obtained.
    • Waxing-up included new positions of gingival margins and zenith points.
    • Silicone index with condensation silicone impression materials made with pressure on the cast to reproduce the details of the wax, then filled after setting with resin material and placed in the patient's mouth.
    • Resin mock-up trimmed with blade to define the correct new gingival level.
    • After the patient accept the mock-up design will used as Gingivectomy guide.
    1. Surgical Procedure: anesthetized the patient using local anesthesia, Surgical incision using 15c blade following CEJ anatomy will be made at each tooth using the Gingivectomy guide as reference to new gingival level and being careful to preserve the gingival papillae without involving the palatal surfaces.
    2. Postoperative care
Study groups in NCT05969132
Study groupRoleWhat they receive
Digital workflow-based ProtocolExperimentalFully digital guided gingivectomy procedure
Receives: Procedure: Fully digital guided gingivectomy procedure
Mock-up workflow-based ProtocolActive comparatorConvectional guided gingivectomy procedure
Receives: Procedure: Convectional guided gingivectomy procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy of both guides

    Intraoral digital scanning for obtaining gingival contour will be made immediately postsurgical, 4 weeks and 2 months after surgery and exported in STL files format.

    Diagnostic waxing-up on poured cast (for group 2) will be digitalized with a model scanner and exported in STL file format.

    Accuracy will be evaluated by:

    • Superimposing postoperative intraoral digital scanning STL files with virtually designed diagnostic waxing STL file (for group 1) and obtain matching differences in height of gingival margin in relation to Muco-gingival junction.
    • Superimposing postoperative intraoral digital scanning STL files with digitized waxing-up STL file (for group 2) and obtain matching differences in height of gingival margin in relation to Muco-gingival junction.

    Measured: Immediately postsurgical, 4 weeks and 2 months after surgery

Secondary outcomes (1)
  1. Patient Satisfaction

    A 5-item custom made questionnaire will give to the patients to be answered for assessing their satisfaction with the whole procedure and the results of the procedure performed.

    1. Post-operative pain (POP): It will be evaluated indirectly based on the mean consumption (in mg) of analgesics (ibuprofen)* after the surgical procedures (Wessel and Tatakis, 2008).
    2. Post-operative results
    3. Post-operative swelling: It will be reported by the patients through the first week (7 days) postsurgically based on the Verbal Rating Scale (VRS) values (absent, slight, moderate and severe) (García et al., 2008).
    4. Surgery time
    5. Procedure as a whole

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2023
  2. Study start31 Dec 2024
  3. Primary completion28 Dec 2025
  4. Study completion1 May 2026

Resources

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
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05969132
Sponsor's protocol ID
FDASU-RecIM122209
Status last verified
May 2026
First submitted
22 Jul 2023
Last updated
3 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ahmed WM, Hans A, Verhaeghe TV, Nguyen C. Managing Excessive Gingival Display Using a Digital Workflow. J Prosthodont. 2020 Jun;29(5):443-447. doi: 10.1111/jopr.13181. Epub 2020 May 6.

    PubMed 32321195
  • Arias DM, Trushkowsky RD, Brea LM, David SB. Treatment of the Patient with Gummy Smile in Conjunction with Digital Smile Approach. Dent Clin North Am. 2015 Jul;59(3):703-16. doi: 10.1016/j.cden.2015.03.007.

    PubMed 26140976
  • Armitage GC. Development of a classification system for periodontal diseases and conditions. Ann Periodontol. 1999 Dec;4(1):1-6. doi: 10.1902/annals.1999.4.1.1.

    PubMed 10863370
  • Bensimon GC. Surgical crown-lengthening procedure to enhance esthetics. Int J Periodontics Restorative Dent. 1999 Aug;19(4):332-41.

    PubMed 10709500
  • Coslet 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 276255
  • Davarpanah M, Jansen CE, Vidjak FM, Etienne D, Kebir M, Martinez H. Restorative and periodontal considerations of short clinical crowns. Int J Periodontics Restorative Dent. 1998 Oct;18(5):424-33.

    PubMed 10093519
  • De Rouck T, Eghbali R, Collys K, De Bruyn H, Cosyn J. The gingival biotype revisited: transparency of the periodontal probe through the gingival margin as a method to discriminate thin from thick gingiva. J Clin Periodontol. 2009 May;36(5):428-33. doi: 10.1111/j.1600-051X.2009.01398.x.

    PubMed 19419444
  • Dolt AH 3rd, Robbins JW. Altered passive eruption: an etiology of short clinical crowns. Quintessence Int. 1997 Jun;28(6):363-72.

    PubMed 9477899
  • Dym H, Pierre R 2nd. Diagnosis and Treatment Approaches to a "Gummy Smile". Dent Clin North Am. 2020 Apr;64(2):341-349. doi: 10.1016/j.cden.2019.12.003. Epub 2020 Jan 24.

    PubMed 32111273
  • Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

    PubMed 17695343
  • Garber 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 9567953
  • Garcia B, Larrazabal C, Penarrocha M, Penarrocha M. Pain and swelling in periapical surgery. A literature update. Med Oral Patol Oral Cir Bucal. 2008 Nov 1;13(11):E726-9.

    PubMed 18978715
  • Geevarghese A, Baskaradoss JK, Alsalem M, Aldahash A, Alfayez W, Alduhaimi T, Alehaideb A, Alsammahi O. Perception of general dentists and laypersons towards altered smile aesthetics. J Orthod Sci. 2019 Aug 8;8:14. doi: 10.4103/jos.JOS_103_18. eCollection 2019.

    PubMed 31497573
  • Goldman, H.M. & Cohen, D.W. (1968). Periodontal Therapy. 4ed. St. Louis: C.V. Mosby Company.

  • Gurrea J, Bruguera A. Wax-up and mock-up. A guide for anterior periodontal and restorative treatments. Int J Esthet Dent. 2014 Summer;9(2):146-62.

    PubMed 24765624

Questions about this trial

What is this clinical trial studying?

A study testing Fully digital guided gingivectomy procedure and Convectional guided gingivectomy procedure in people with Altered Passive Eruption of Teeth, 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 8 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 Jun 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 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?

Accuracy of both guides (time frame: Immediately postsurgical, 4 weeks and 2 months after 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 NCT05969132, which also lists 28 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 3 Jun 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in