The Effect of Platform-Matching Versus Platform-Switching Dental Implants on Peri-implant Hard and Soft Tissue Healing

NCT02536716 | Completed DMC

• 1 other identifier: 15.0448
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

To compare platform-switched implants to platform-matched implants for replacement of a single missing tooth and their effect on: 1) Interproximal alveolar crest level in relation to implant platform. 2) Buccal implant recession. 3) Presence or absence of black triangle apical to the contact point. 4) Implant Success. 5) Adequate buccal tissue thickness.

Conditions

Missing Tooth

Keywords

Dental Implant

Outcome Measures

Primary Outcomes (1)

• Marginal alveolar bone loss

  Bone loss will be measured radiographically using a stent

  12-months post dental implant placement

Secondary Outcomes (3)

• Buccal implant recession

  12-months post dental implant placement

• Papilla fill

  12-months post dental implant placement

• Buccal soft tissue thickness around implant

  12-months post dental implant placement

Study Arms (2)

Platform-matched dental implant

ACTIVE COMPARATOR

Platform-matched dental implant placement to measure marginal bone loss, gingival margin position, and papilla fill.

Procedure: Platform-matched dental implant

Platform-switched dental implant

EXPERIMENTAL

Platform-switched dental implant placement to measure marginal bone loss, gingival margin position, and papilla fill.

Procedure: Platform-switched dental implant

Interventions

Platform-matched dental implant PROCEDURE

A platform-matched dental implant will be placed surgically, restored with a crown and evaluated for up to 12 months.

Platform-matched dental implant

Platform-switched dental implant PROCEDURE

A platform-switched dental implant will be placed surgically, restored with a crown and evaluated for up to 12 months.

Platform-switched dental implant

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Have one edentulous site bordered by 2 teeth.
• \. Healthy persons at least 18 years old.
• \. Understands and has signed the informed consent.

You may not qualify if:

• \. Patients with uncontrolled diabetes, immune disease, or systemic disease that significantly affects the periodontium.
• \. Previous head and neck radiation.
• \. Patients who have been on IV bisphosphonates or oral bisphosphonates for \> 3 years.
• \. Smokers.
• \. Patients who need prophylactic antibiotics prior to dental procedures.
• \. Patients with allergy to any medication or material used in the study.
• \. Chemotherapy in the previous 12 months.
• \. Severe psychological problems.
• \. Patients unable to sign the informed consent.
• \. Pregnant patients.
• \. History of allergy to common dentifrice ingredients.

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Henry Greenwell, DMD

  University of Louisville

  PRINCIPAL INVESTIGATOR

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: Graduate Periodontics Program Director

Study Record Dates

• First Submitted: August 28, 2015
• First Posted: September 1, 2015
• Study Start: January 12, 2016
• Primary Completion: July 21, 2017
• Study Completion: July 21, 2017
• Last Updated: September 10, 2020

Record last verified: 2020-09

Locations

US (1)