NCT02842385

Brief Summary

Changes in the marginal bone level surrounding the implant are the frequently used parameters in assessing the short- and long-term success. Multiple biological and biomechanical factors have been reported to adversely affect marginal bone level. Recently, initial vertical mucosal tissue thickness has also been reported to have an impact on bone stability.The hypothesis of present study is that soft tissue thickness on implant placement has no positive impact of crestal bone remodeling.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 22, 2016

Completed
Last Updated

July 22, 2016

Status Verified

July 1, 2016

Enrollment Period

2.1 years

First QC Date

July 11, 2016

Last Update Submit

July 20, 2016

Conditions

Tooth LossEdentulousness

Keywords

soft tissue thicknessdental implantcrestal bone loss

Outcome Measures

Primary Outcomes (4)

  • Crestal bone loss

    Crestal bone loss was measured on radiographs between baseline-4th month after placement

    Change from baseline crestal bone level at 4th month after placement,

  • Crestal bone loss

    Crestal bone loss was measured on radiographs between baseline-6th month after placement

    Change from baseline crestal bone level at 6th month after placement,

  • Crestal bone loss

    Crestal bone loss was measured on radiographs between baseline-12th month after placement

    Change from baseline crestal bone level at 12th month after placement,

  • Crestal bone loss

    Crestal bone loss was measured on radiographs between baseline-18th month after placement

    Change from baseline crestal bone level at 18th month after placement,

Secondary Outcomes (16)

  • Probing depth

    Evaluation of probing depth at 4th month after placement (mm)

  • Probing depth

    Evaluation of probing depth at 6th month after placement (mm)

  • Probing depth

    Evaluation of probing depth at 12th month after placement (mm)

  • Probing depth

    Evaluation of probing depth at 18th month after placement (mm)

  • Keratinized tissue level

    Evaluation of keratinized tissue level at 4th month after placement (mm)

  • +11 more secondary outcomes

Study Arms (4)

Nonsubmerged thick group

ACTIVE COMPARATOR

Nonsubmerged type of implants placed with thick (\>3 mm) soft tissue

Other: Implant

Nonsubmerged thin group

ACTIVE COMPARATOR

Nonsubmerged type of implants placed with thin (\<3 mm) soft tissue

Other: Implant

Submerged thick group

ACTIVE COMPARATOR

Submerged type of implants placed with thick (\>3 mm) soft tissue

Other: Implant

Submerged thin group

ACTIVE COMPARATOR

Submerged type of implants placed with thin (\<3 mm) soft tissue

Other: Implant

Interventions

ImplantOTHER

One or two stages of implants within thin and thick gingiva were monitored 1.5 year after placement

Nonsubmerged thick groupNonsubmerged thin groupSubmerged thick groupSubmerged thin group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being older than 18 years of age
  • generally healthy patients, no medical contraindication for implant surgery
  • missing teeth in upper jaw posterior and more than one tooth in neighbourhood area
  • no bone augmentation procedures before and during implant placement.

You may not qualify if:

  • poor oral hygiene
  • history of periodontitis
  • smoking
  • diabetes
  • alcoholism
  • taking medication which interferes soft and hard tissue healing
  • bruxism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tooth Loss

Interventions

Drug Implants

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth Diseases

Intervention Hierarchy (Ancestors)

Delayed-Action PreparationsDosage FormsPharmaceutical Preparations

Study Officials

  • Deniz Cengiz Özkaya, PhD,DDS

    Ege University, School of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, DDS

Study Record Dates

First Submitted

July 11, 2016

First Posted

July 22, 2016

Study Start

October 1, 2009

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

July 22, 2016

Record last verified: 2016-07