Comparison of Dual Digitally Guided vs Conventional Crown Lengthening (DIGICROWN)
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.
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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Damascus, Syrië
- School of Dental Medicine
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- Poor oral hygiene
- Smokers
- Pregnancy or lactation
- Systemic diseases affecting periodontal tissues
- Previous periodontal surgery in the study area
- Active periodontal disease
- Presence of periapical pathology in the study area
- Ongoing orthodontic treatment
- Gummy smile due to skeletal or muscular causes
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Conventional Crown Lengthening
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.
|
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.
|
|
Experimenteel: Dual Digitally Guided Crown Lengthening
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.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Gain in Clinical Crown Length
Tijdsspanne: 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.
|
Baseline and 3 months postoperatively
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Surgical Operating Time
Tijdsspanne: During surgery (intraoperative)
|
Total duration of the surgical procedure measured in minutes from the first incision to completion of osteotomy.
|
During surgery (intraoperative)
|
|
Relative Gingival Margin Level
Tijdsspanne: Baseline, 1 week, and 3 months postoperatively
|
Measurement of gingival margin position (mm) relative to a fixed reference point to evaluate soft tissue stability.
|
Baseline, 1 week, and 3 months postoperatively
|
|
Probing Depth
Tijdsspanne: Baseline and 3 months postoperatively
|
Periodontal probing depth (mm) measured at standardized sites using a periodontal probe.
|
Baseline and 3 months postoperatively
|
|
Gingival Index (GI)
Tijdsspanne: Baseline and 3 months postoperatively
|
Assessment of gingival inflammation using the Gingival Index scoring system.
|
Baseline and 3 months postoperatively
|
|
Plaque Index (PI)
Tijdsspanne: Baseline and 3 months postoperatively
|
Assessment of oral hygiene status using the Plaque Index scoring system.
|
Baseline and 3 months postoperatively
|
|
Bleeding on Probing (BOP)
Tijdsspanne: Baseline and 3 months postoperatively
|
Presence or absence of bleeding upon gentle probing, expressed as a percentage of bleeding sites.
|
Baseline and 3 months postoperatively
|
|
Keratinized Gingival Height
Tijdsspanne: Baseline, 1 week, and 3 months postoperatively
|
Width of keratinized gingiva (mm) measured from the gingival margin to the mucogingival junction.
|
Baseline, 1 week, and 3 months postoperatively
|
|
Gingival Thickness
Tijdsspanne: Baseline and 3 months postoperatively
|
Thickness of gingival tissue (mm) measured using transgingival probing or ultrasound methods.
|
Baseline and 3 months postoperatively
|
|
Postoperative Pain (Visual Analog Scale)
Tijdsspanne: 24 hours, 7 days, and 14 days postoperatively
|
Patient-reported pain assessed using a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable).
|
24 hours, 7 days, and 14 days postoperatively
|
|
Patient Satisfaction (Visual Analog Scale)
Tijdsspanne: 7 days and 3 months postoperatively
|
Patient satisfaction with the esthetic and functional outcome measured using a Visual Analogue Scale (VAS).
|
7 days and 3 months postoperatively
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Raghad Alrefaai, DDs, Damascus University
- Studie stoel: Razan Khattab, PhD, Damascus University
- Studie directeur: Saleh Al Kurdi, PhD, Arab International University
Publicaties en nuttige links
Algemene publicaties
- Malkinson 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.
- 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.
- Marzadori 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.
- Bynum J. Treatment of a "Gummy Smile": Understanding Etiology is Key to Success. Compend Contin Educ Dent. 2016 Feb;37(2):114-22.
- Carrera 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.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- DN-10062024-3764
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .