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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03804281
Other study ID # Dentaris192018
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date August 1, 2020

Study information

Verified date January 2019
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the study compare gingival margin stability following conventional approach versus microsurgical approach of esthetic crown lengthening in management of patients with short clinical crowns in the upper anterior region.In management of patients with short clinical crowns in the upper anterior region, there is no difference in gingival margin stability between conventional and microsurgical approaches of esthetic crown lengthening.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 24
Est. completion date August 1, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with healthy systemic condition.

- Adult patients ? 18 years old.

- The presence of the six upper anterior teeth.

- Absence of sites with attachment loss and probing depth (PD) >3 mm

- Keratinized gingiva of at least 2mm width.

- Compliance with good oral hygiene.

- Patients accepts 6-months follow-up period (cooperative patients).

- Patients provides an informed consent

Exclusion Criteria:

- Gummy smile with normal tooth proportions

- Presence of prosthetic crowns

- Extensive restorations

- Extensive incisal edge attrition.

- Misalignment on maxillary anterior teeth.

- Smokers ? 10 cigarettes / day.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Test group
The surgery will be done with the use of 4x magnification loop, the knives are micro blades and micro-sutures 7//0 used with the microsurgical instruments kit
Control group
esthetic crown lengthening with conventional approach with an internal bevel incision, following CEJ anatomy, this will be followed by an intra-sulcular incision, removal of the strip of outlined marginal gingiva and elevation of a mucoperiosteal ?ap to the level of the alveolar bone crest.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary Mid-buccal gingival margin level periodontal probe with William's graduation will be used to measure the distance from the CEJ to the gingival margin at the mid-buccal surface 6 months
Secondary Pink Esthetic Score (PES) The PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture. Each variable shall be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The mesial and distal papilla will be evaluated for completeness, incompleteness or absence 6 months
Secondary Post-Surgical swelling will be evaluated post-surgically with Verbal Rating Scale with words ranging from (absent-slight-moderate-intense) Absent (no swelling), Slight (intraoral swelling at the operated area), Moderate (moderate intraoral swelling at the operated area) and Intense (intensive extra oral swelling extending beyond the operated area). 7days
Secondary Post-Surgical Patient Satisfaction: 3-item questionnaire A 3-item questionnaire is asked and the patients shall use a 7-point answer scale 6 months
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