Peri-implant Mucosal Changes Over Time Following Implant Provisional Removal in the Esthetic Zone

NCT06783595 | Recruiting

• 1 other identifier: 5230566
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The study will examine the temporary volumetric change that happens in the gums around an implant crown when the crown is removed. The main question of the study is "how much time has to pass to see a significant change, especially when there could be a need to make a mold of the surrounding gum to make a new crown?" The area of the implant crown will be scanned with an intra-oral scanner over a period of 15 minutes.

Conditions

Tooth Loss; Implant Site Reaction

Keywords

immediate implant placement; provisional; impression

Outcome Measures

Primary Outcomes (1)

• Peri-implant mucosal volumetric change

  The mucosal volumetric change will be a composite measurement of the outside and inside portion of the peri-implant gum area by a 3D analyzing software. The 3D image that has been captured from an intra-oral scan will be analyzed during the time interval mentioned in the study description. This measurement is representing the horizontal change, and will be recorded in millimeters (mm). The critical analysis will be placed as changes from 0.5mm. Any change more than 0.5mm will be considered a large amount of change.

  Change between baseline and 15 minutes post initial crown removal

Secondary Outcomes (1)

• Vertical gingival margin discrepancy

  Change between baseline and 15 minutes post initial crown removal

Interventions

intraoral scan OTHER

Device that scans the mouth with by taking numerous pictures of the mouth and stitches them together to form a three-dimensional copy of the patient teeth.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients selected for the participation in the study will be solely from the Center of Implant Dentistry at Loma Linda University School of Dentistry.

You may qualify if:

• Patient must have a maxillary anterior immediate implant and provisionalization treatment completed.
• The adjacent tooth next to the implant should be a natural tooth
• The temporary crown must have been in place for a minimum of 4 months
• The patient needs to be of general good health, with no significant medical history or social habits that might directly affect the hard and soft tissue
• Patient must have generally good oral hygiene without any history of gum disease or gum recession of other teeth around the region of interest

You may not qualify if:

• Patient with an implant crown that has no teeth next to the implant crown
• Patients who have an active gum disease

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University - Center of Implant Dentistry

Loma Linda, California, 92350, United States

RECRUITING

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Joseph Kan, DDS, MS

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ji Yeon Chung, DDS

CONTACT

9095584983; jichung@students.llu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: April 24, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)