NCT06801548

Brief 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 approach able to introduce a more precise, accuracy and reliability technique with more patient satisfaction compared to the mock-up guided method?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 30, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

February 20, 2025

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
Last Updated

February 25, 2025

Status Verified

March 1, 2024

Enrollment Period

23 days

First QC Date

January 25, 2025

Last Update Submit

February 24, 2025

Conditions

Gummy Smile

Keywords

Esthetic crown lengtheningGingivectomyGuided surgeryWax-upDigital

Outcome Measures

Primary Outcomes (1)

  • 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

    Immediately after the surgery

Secondary Outcomes (2)

  • Patient satisfaction

    3 months after the surgery

  • Marginal stability

    4 weeks and 3 months

Study Arms (2)

Conventional arm

ACTIVE COMPARATOR

Esthetic crown lengthening surgery is done using mock-up based guide

Procedure: Esthetic crown lengthening surgery

Digital arm

ACTIVE COMPARATOR

Esthetic crown lengthening surgery is done using digital guide

Procedure: Esthetic crown lengthening surgery using Digital guide

Interventions

Esthetic crown lengthening surgeryPROCEDURE

Esthetic crown lengthening surgery using mock-up based guide

Conventional arm
Esthetic crown lengthening surgery using Digital guidePROCEDURE

Esthetic crown lengthening surgery using digital guide based on DSD and CBCT

Digital arm

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant and lactating females.
  • Heavy smoker ≥ 10 cigarettes/day.
  • Poor oral hygiene.
  • Patients with occlusal or malalignment problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry - Ain Shams University

Cairo, 11566, Egypt

Location

Related Publications (10)

  • 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.

    PMID: 24460748BACKGROUND

  • Lee EA. Aesthetic crown lengthening: classification, biologic rationale, and treatment planning considerations. Pract Proced Aesthet Dent. 2004 Nov-Dec;16(10):769-78; quiz 780.

    PMID: 15739921BACKGROUND

  • Ganji 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.

    PMID: 22969804BACKGROUND

  • Jepsen 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.

    PMID: 29926943BACKGROUND

  • Shobha 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.

    PMID: 21760669BACKGROUND

  • Nugala 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.

    PMID: 22368328BACKGROUND

  • Liu 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.

    PMID: 28689907BACKGROUND

  • 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.

    PMID: 9567953BACKGROUND

  • 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.

    PMID: 276255BACKGROUND

  • Bhola 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.

    PMID: 26133145BACKGROUND

Study Officials

  • Ahmed E Amr, Ass.Prof

    Faculty of Dentistry - Ain Shams University

    STUDY DIRECTOR

Central Study Contacts

Abdallah A. Aref, Master student

CONTACT

00201111711467abdallah.aref.std@dent.asu.edu.eg

Doaa A Khattab, Ass.Prof

CONTACT

00201006814258Dr.doaa.adel-khattab@dent.asu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Oral Medicine and Periodontology

Study Record Dates

First Submitted

January 25, 2025

First Posted

January 30, 2025

Study Start

February 20, 2025

Primary Completion

March 15, 2025

Study Completion

May 20, 2025

Last Updated

February 25, 2025

Record last verified: 2024-03

Locations

EG(1)