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Completed

NCT Number: NCT05512312

Computer Guided Esthetic Crown Lengthening

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.

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Egypt

About this study

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:

Patient satisfaction: was assessed using visual analogue scale at 24 hours, 7 days and 14 days post operatively. (Zero is for minimum pain and ten is for maximum pain).

Gingival margin stability: The position of gingival margin in relation to a reference point was evaluated immediately after surgery, 3 months and 6 months healing period .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional Esthetic crown lengthening

Procedure

Conventional Surgical Esthetic Crown Lengthening

Computer guided Esthetic crown lengthening

Procedure

Computer guided Esthetic crown lengthening

Primary outcomes

  1. 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

  2. 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

  1. Patient satisfaction

    Time frame: 1 day - 1 week - 2 weeks post operative

    will be assessed using numerical visual analogue scale (scale of zero - no pain to ten- maximum pain)

  2. Gingival margin stability

    Time frame: Baseline - 3 months post operative - 6 months post operative

    The position of gingival margin in reference to an index is measured from the incisal edge to the free gingival margin

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 23, 2022
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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