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

Not Applicable

Completed

• Conditions: Gingival Tissue
• Interventions: Device: Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT)

• Registration Number: NCT02925078
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-10-03
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-05
• Study Start: 2016-11-21
• Primary Completion: 2019-12-16
• Study Completion: 2019-12-16
• Status Verified: 2020-10
• Results First Submitted: 2020-10-01
• Results First Submitted QC: 2020-10-01
• Last Update Submitted: 2020-10-01
• Results First Posted: 2020-10-26
• Last Update Posted: 2020-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Peri-implant Probing Depth Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up.	12 months	Change in probing depths (measured in millimeters) around the dental implant between the crown delivery visit and the 12 month follow-up visit.
Radiographic Peri-implant Bone Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up.	12 months	Radiographic change in remaining bone level (measured in millimeters) between the surgery visit (baseline) and the 12 month follow up visit.

Trial Locations

Locations (1)

University of Michigan School of Dentistry; 🇺🇸 Ann Arbor, Michigan, United States