Influence of Mucosa Tissue Thickness on Marginal Bone Loss of Implants With Smooth Collars

University of Michigan

Status: Completed

Conditions: Gingival Tissue

Treatments: Device: Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT)

Study type: Interventional

Funder types: Other

Identifiers

NCT02925078

HUM00095933

Details and patient eligibility

About

The primary objective of this study is to compare the amount of implant marginal bone loss radiographically and probing depth in between thin and thick mucosa group that will receive a machined collar implant.

Null hypothesis is mucosa thickness does not affect implant marginal bone loss on implant with smooth collar.

Full description

Twenty eight adult patients who fulfill the inclusion criteria will be divided into 2 groups based upon the mucosa thickness (<2 mm and ≥2 mm). A signed written informed consent will be obtained from all subjects. Subjects will not be screened or treated until an informed consent has been obtained. Patient information will be protected according to the privacy regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA).

The enrolled patients will receive implants with 1 mm polished collar. Implants will be restored at 4 (±1) months after placement. Outcome analyses will be performed until 1 (±1 month) year after loading and clinical and radiographic parameters will be evaluated to compare clinical outcomes between groups. The primary outcome is implant marginal bone loss and probing depth from clinical and radiographic measurements.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or Female
• Aged ≥18
• In need of one dental implant in the Maxillary or Mandibular area, can be an anterior, premolar, or 1st molar tooth
• Natural adjacent teeth
• Bone height of ≥10mm
• Bone width of ≥5mm
• Good oral hygiene
• Stable periodontium
• Willingness to fulfill all study requirements

Exclusion criteria

• Need bone augmentation
• Need one dental implant that is a 2nd or 3rd molar tooth
• Current smoker or quit smoking less than one year
• Pregnant or plan to get pregnant
• Uncontrolled diabetes (HbA1C > 7)
• Medical conditions that may influence the outcome of the study (neurologic or psychiatric disorders, systemic infections )
• Current use of oral bisphosphonates
• History of IV bisphosphonates
• History of radiation therapy in the head and neck area within 4 years
• Poor oral hygiene (plaque score more than 40% based on O'Leary plaque score)
• Once a group has been filled, subjects who meet the criteria of that group will be excluded

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

<2 mm mucosa thickness

Other group

Description:

A Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT) will be placed in subjects that have \<2 mm mucosa thickness.

Treatment:

Device: Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT)

≥2 mm mucosa thickness

Other group

Description:

A Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT) will be placed in subjects that have ≥2 mm mucosa thickness.

Treatment:

Device: Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT)