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OpenTrials
Completed

NCT Number: NCT02925078

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Placement of implant in a subject with <2 mm mucosa thickness or a subject with ≥2 mm mucosa thickness.

Primary outcomes

  1. Radiographic Peri-implant Bone Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up.

    Time frame: 12 months

    Radiographic change in remaining bone level (measured in millimeters) between the surgery visit (baseline) and the 12 month follow up visit.

  2. Peri-implant Probing Depth Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

The Influence of Mucosa Tissue Thickness on Marginal Bone Loss of Implants With Smooth Collars: A Prospective Controlled Trial

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 5, 2016
Registry last updated
Oct 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.