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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Damascus, Syrie
- School of Dental Medicine
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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.
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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.
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Expérimental: 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.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Gain in Clinical Crown Length
Délai: Baseline and 3 months postoperatively
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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.
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Baseline and 3 months postoperatively
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Surgical Operating Time
Délai: During surgery (intraoperative)
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Total duration of the surgical procedure measured in minutes from the first incision to completion of osteotomy.
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During surgery (intraoperative)
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Relative Gingival Margin Level
Délai: Baseline, 1 week, and 3 months postoperatively
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Measurement of gingival margin position (mm) relative to a fixed reference point to evaluate soft tissue stability.
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Baseline, 1 week, and 3 months postoperatively
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Probing Depth
Délai: Baseline and 3 months postoperatively
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Periodontal probing depth (mm) measured at standardized sites using a periodontal probe.
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Baseline and 3 months postoperatively
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Gingival Index (GI)
Délai: Baseline and 3 months postoperatively
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Assessment of gingival inflammation using the Gingival Index scoring system.
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Baseline and 3 months postoperatively
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Plaque Index (PI)
Délai: Baseline and 3 months postoperatively
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Assessment of oral hygiene status using the Plaque Index scoring system.
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Baseline and 3 months postoperatively
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Bleeding on Probing (BOP)
Délai: Baseline and 3 months postoperatively
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Presence or absence of bleeding upon gentle probing, expressed as a percentage of bleeding sites.
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Baseline and 3 months postoperatively
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Keratinized Gingival Height
Délai: Baseline, 1 week, and 3 months postoperatively
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Width of keratinized gingiva (mm) measured from the gingival margin to the mucogingival junction.
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Baseline, 1 week, and 3 months postoperatively
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Gingival Thickness
Délai: Baseline and 3 months postoperatively
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Thickness of gingival tissue (mm) measured using transgingival probing or ultrasound methods.
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Baseline and 3 months postoperatively
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Postoperative Pain (Visual Analog Scale)
Délai: 24 hours, 7 days, and 14 days postoperatively
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Patient-reported pain assessed using a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable).
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24 hours, 7 days, and 14 days postoperatively
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Patient Satisfaction (Visual Analog Scale)
Délai: 7 days and 3 months postoperatively
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Patient satisfaction with the esthetic and functional outcome measured using a Visual Analogue Scale (VAS).
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7 days and 3 months postoperatively
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Raghad Alrefaai, DDs, Damascus University
- Chaise d'étude: Razan Khattab, PhD, Damascus University
- Directeur d'études: Saleh Al Kurdi, PhD, Arab International University
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- DN-10062024-3764
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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