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Clinical Trials/NCT05512312
NCT05512312CompletedNot Applicable

Treatment of Excessive Gingival Display Using Conventional Esthetic Crown Lengthening Versus Computer Guided Esthetic Crown Lengthening: (A Randomized Clinical Trial)

Ain Shams University1 site in 1 country16 target enrollmentStarted: January 2, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
16
Locations
1
Primary Endpoint
Wound Healing

Study Overview

Brief Summary

The objective of the present study was to evaluate the effectiveness of surgical esthetic crown lengthening using digitally assisted 3D printed surgical stents in management of excessive gingival display due to altered passive eruption.

Detailed Description

The objective of the present study was to evaluate the effectiveness of surgical esthetic crown lengthening using digitally assisted 3D printed surgical stents in management of excessive gingival display due to altered passive eruption.

Primary objectives:

Wound healing Score: the clinical features of periodontal wound healing were measured according to Hagenaars et al using the following parameters: swelling of the soft tissue , color of the gingiva, probing pocket depth, bleeding index, plaque index, clinical attachment level. These signs were assessed at 1 week, 3 months and 6 months post-operative.

Operating time: the time needed to complete each procedure was calculated in minutes by using a stopwatch from the time of the first incision till the completion of bone removal.

Secondary objectives:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Males and females within age range of 20-40 years.
  • •Systemic (medically) free individuals.
  • •Excessive gingival display in the esthetic zone (more than 3mm of gingival display at full smiling)
  • •Patients with good oral hygiene.

Exclusion Criteria

  • •Smokers (15)
  • •Teeth with compromised periodontium.
  • •Pregnant and lactating females.
  • •The vulnerable group: patients with mental or physical disabilities.
  • •Patients with parafunctional habits.
  • •Medications that affect periodontal wound healing.
  • •Periodontal surgery in the esthetic zone in the past 6 months.

Arms & Interventions

Control Group

Active Comparator

Eight patients indicated for ECL were managed by conventional crown lengthening.

Intervention: Conventional Esthetic crown lengthening (Procedure)

Test Group

Active Comparator

Eight patients indicated for ECL were treated using digitally assisted crown lengthening utilizing 3D printed surgical stents.

Intervention: Computer guided Esthetic crown lengthening (Procedure)

Outcomes

Primary Outcomes

Wound Healing

Time Frame: Change in soft tissue features from 1 week to 6 months post operative

the clinical features of periodontal wound healing were measured according to Hagenaars et al using the following parameters: color of the gingiva (C) (a score of 0-2) 0=no redness, 1=moderate redness, 2=pronounced redness

Operating time

Time Frame: During surgery

the time needed to complete each procedure from the first incision till the completion of bone removal

Secondary Outcomes

  • Patient satisfaction(1 day - 1 week - 2 weeks post operative)
  • Gingival margin stability(Baseline - 3 months post operative - 6 months post operative)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eman Borham

Teaching Assistant, Faculty of Dentistry, Misr International University

Ain Shams University

Study Sites (1)

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