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Comparison of Dual Digitally Guided vs Conventional Crown Lengthening (DIGICROWN)

4. maj 2026 opdateret af: Arab International University

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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

24

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Syrien
      • Damascus, Syrien
        • School of Dental Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Procedure: Conventional Crown Lengthening
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.
Eksperimentel: 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.
Procedure: Dual Digitally Guided Crown Lengthening
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gain in Clinical Crown Length
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Surgical Operating Time
Tidsramme: During surgery (intraoperative)
Total duration of the surgical procedure measured in minutes from the first incision to completion of osteotomy.
During surgery (intraoperative)
Postoperative Pain (VAS)
Tidsramme: 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 (VAS)
Tidsramme: 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
Relative Gingival Margin Level
Tidsramme: 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
Tidsramme: 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)
Tidsramme: Baseline and 3 months postoperatively
Assessment of gingival inflammation using the Gingival Index scoring system.
Baseline and 3 months postoperatively
Plaque Index (PI)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline and 3 months postoperatively
Thickness of gingival tissue (mm) measured using transgingival probing or ultrasound methods.
Baseline and 3 months postoperatively

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Arab International University

Samarbejdspartnere

Damascus University

Efterforskere

  • Ledende efterforsker: Raghad Alrefaai, DDs, Damascus University
  • Studiestol: Razan Khattab, PhD, Damascus University
  • Studieleder: Saleh Al Kurdi, PhD, Arab International University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juli 2024

Primær færdiggørelse (Faktiske)

15. oktober 2025

Studieafslutning (Faktiske)

25. februar 2026

Datoer for studieregistrering

Først indsendt

4. maj 2026

Først indsendt, der opfyldte QC-kriterier

4. maj 2026

Først opslået (Faktiske)

8. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DN-10062024-3764

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Conventional Crown Lengthening

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