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OpenTrials
Completed

NCT Number: NCT03064217

Intraoral Imaging at Clinical Crown Lengthening

Crown lengthening surgery is done when a tooth needs to be fixed with a crown. Sometimes, not enough of the tooth sticks out above the gum to support a crown. This can happen when a tooth breaks off at the gum line, or when a crown or filling falls out of a tooth and there is decay underneath. To place a crown, the dentist needs to expose more of the tooth. This is done by removing some gum tissue or bone.

After surgery, the area will heal in about three months. Then, making a crown can begin. This healing period often delays the delivery a final crown. This study is investing a way to make the final impression at the surgery to expedite the delivery of a final crown.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Advanced General Dentistry at UMB DS, Baltimore, Maryland, United States

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About this study

The purpose of this prospective study is to evaluate clinical and radiographic outcomes of single unsplinted fixed restorations made with digital intraoral imaging in conjunction with clinical crown lengthening procedures (CLPs) compared ones fabricated by the conventional protocol.

Specific Aim 1: To evaluate the clinical outcomes between the experimental group (the digital impression taking at clinical crown lengthening procedures) and the control group (the conventional protocol) Hypothesis: There will be no differences in clinical parameters around the teeth between the two groups.

Approach: The investigators will conduct a prospective clinical study and will compare the changes in gingival recession, the width of keratinized gingiva, and pocket depths around the teeth between the two groups.

Specific Aim 2: To evaluate the radiographic outcome between the experimental group and the control group Hypothesis: There will be no difference in crestal bone level around teeth between the two groups.

Approach: The study will investigate the difference in crestal bone level around the teeth at baseline and 12 months between the two groups.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • age >18 years
  • a single-unsplinted crown needed
  • the tooth must be in the area from the canine to the second molars
  • a clinical crown lengthening is required to fabricate a crown

Exclusion criteria

  • uncontrolled hypertension
  • diabetes mellitus
  • subjects with a history of a long-term use of corticosteroid (> 6 months)
  • subjects with a history of taking oral/IV bisphosphonates within the past 2 years
  • smokers.

Treatment and study plan

Making impression at surgery

Device

Making impression at surgery

Primary outcomes

  1. Pocket Depth

    Time frame: 12 months

    Changes in pocket depths (the distance from the gingival margin to pocket base) at 12 months from the baseline

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

The Use of Intraoral Imaging at Clinical Crown Lengthening Procedures

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Feb 24, 2017
Registry last updated
Feb 7, 2025

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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