Intraoral Imaging at Clinical Crown Lengthening

NCT03064217 | Completed Results FDA Device

• 1 other identifier: HP-00073913
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Dental Caries of Root Surface; Surgery

Keywords

Clinical crown lengthening; intraoral imaging; Emax crown

Outcome Measures

Primary Outcomes (1)

• Pocket Depth

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

  12 months

Study Arms (2)

Making impression at surgery

EXPERIMENTAL

Making impression at surgery

Device: Making impression at surgery

Making impression 8 weeks after surgery

NO INTERVENTION

Making impression 8 weeks after surgery

Interventions

Making impression at surgery DEVICE

Making impression at surgery

Making impression at surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (2)

Advanced General Dentistry at UMB DS

Baltimore, Maryland, 21201, United States

Location

University of Maryland School of Dentistry

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Root Caries

Condition Hierarchy (Ancestors)

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Se-Lim Oh
• Organization: University of Maryland, Baltimore

soh@umaryland.edu

4107063708

Study Officials

• Se-Lim Oh, DMD

  University of Maryland School of Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: February 24, 2017
• Study Start: May 25, 2017
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: February 7, 2025
• Results First Posted: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)