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Study to Evaluate Bone and Gum Dimension Changes Around Dental Implants Placed in Different Positions in Bone.

Primary Purpose

Mouth, Edentulous

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ankylos dental endosseous implants-Sub-crestal
Ankylos dental endosseous implants-Epi-crestal
Sponsored by
Dentsply International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mouth, Edentulous

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Subjects must have read, understood and signed an informed consent form;
  2. Subjects must be 18 to 70 years of age;
  3. Subjects must be able and willing to follow study procedures and instructions;
  4. Subjects must have indication to receive two implants in a bilateral maxillary or mandibular edentulous areas (for at least 4 months post extraction) in areas of pre-molars (first or second) and molars (first or second);
  5. Sufficient width and height of bone to place at least 8mm length and any compatible in diameter Ankylos implant;
  6. Sufficient vertical clearance to place a single tooth crown replacement;
  7. No apical disorder/inflammation at the area of the implant site.

Exclusion Criteria:

  1. Subjects participating in other clinical studies within 1 month prior to screening and/or involving therapeutic intervention (either medical or dental) that could affect bone or soft tissue healing;
  2. Female subjects who are pregnant or lactating, or who intend to become pregnant during the study period following entrance into the study;
  3. Subjects with parafunctional habits;
  4. Subjects who have failed to maintain good plaque control;
  5. Subjects with any systemic condition like uncontrolled diabetes mellitus, cancer, HIV, disorders that compromise wound healing, chronic high dose steroid therapy, bone metabolic diseases, radiation or other immuno-suppressive therapy which would preclude periodontal surgery;
  6. Absence of occlusal stability in centric occlusion;
  7. Subjects with the presence of acute infectious lesions in the areas intended for surgery;
  8. History within the last 3 months of weekly or more frequent use of smokeless chewing tobacco, pipe or cigar smoking and cigarette smoking (greater than 10 cigarettes per day)
  9. Present alcohol or drug abuse;
  10. Angulation requirements of the restoration exceeding approximately 15 degrees;
  11. Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration (e.g. calcium channel blocker, dilantin).

Sites / Locations

  • Bluestone Center for Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Implants placed at sub-crestal position.

Epi-crestal implants.

Arm Description

Ankylos dental endosseous implants-Sub-crestal

Ankylos dental endosseous implants-Epi-crestal

Outcomes

Primary Outcome Measures

Change in Marginal Bone Level (MBL)
Changes in MBLs at 18 months and 30 months after implant placement were chosen as primary outcome parameters. Results are described as mean values and standard deviations. Note: Mean changes in MBL for epicrestal and subcrestal placements at lingual and buccal sites is also referred to as "mid-facial bone levels". To determine MBL changes between T0 and each follow-up visit, MBLs at T0 were subtracted from the complementary values for that implant at T18 and T30.

Secondary Outcome Measures

Change in Mid-Buccal Soft Tissue Height
Soft tissue levels were measured clinically from a fixed reference point to the mid buccal soft tissue margin using a stent. Measurements were made from fixed reference points, by using a stent to perform clinical measurements in a reproducible position.
Change of Interproximal Levels After Final Restoration
Analysis of interproximal bone height change measured by periapical radiographs. The height of the papilla will be assessed at the mesial and distal sites of the implants, by means of the published "papilla Jemt index". Measurements will be assessed by reviewing the clinical photographs. Reference: Jemt, T. (1997) "Regeneration of gingival papillae after single-implant treatment". International Journal of Periodontics and Restorative Dentistry 17: 326-333.
Change in Marginal Bone Level (MBL)
Changes in MBLs at 66 months after implant placement were chosen as a secondary outcome parameter. Results are described as mean values and standard deviations. Note: Mean changes in MBL for epicrestal and subcrestal placements at lingual and buccal sites is also referred to as "mid-facial bone levels". To determine MBL changes between T0 and each follow-up visit, MBLs at T0 were subtracted from the complementary values for that implant at T18, T30 and T66.

Full Information

First Posted
December 31, 2012
Last Updated
December 1, 2022
Sponsor
Dentsply International
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1. Study Identification

Unique Protocol Identification Number
NCT01759537
Brief Title
Study to Evaluate Bone and Gum Dimension Changes Around Dental Implants Placed in Different Positions in Bone.
Official Title
Evaluation of Changes of Hard and Soft Tissues After Epi-crestal and Sub-crestal Placement of Ankylos Dental Implants.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 2012 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dentsply International

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to test two standard of care techniques of placing dental implants, and to compare how people's bones and gums respond to two different depths at which implants are placed.
Detailed Description
The purpose of this study is to test epicrestal and subcrestal placement of dental implants, and to compare how people's bones and gums respond to two different depths at which implants are placed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mouth, Edentulous

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This was a split mouth study design in which the same patient was used for both arms.
Masking
Investigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Implants placed at sub-crestal position.
Arm Type
Experimental
Arm Description
Ankylos dental endosseous implants-Sub-crestal
Arm Title
Epi-crestal implants.
Arm Type
Active Comparator
Arm Description
Ankylos dental endosseous implants-Epi-crestal
Intervention Type
Device
Intervention Name(s)
Ankylos dental endosseous implants-Sub-crestal
Intervention Description
Implants placed subcrestally
Intervention Type
Device
Intervention Name(s)
Ankylos dental endosseous implants-Epi-crestal
Intervention Description
Implants placed Epi-crestally
Primary Outcome Measure Information:
Title
Change in Marginal Bone Level (MBL)
Description
Changes in MBLs at 18 months and 30 months after implant placement were chosen as primary outcome parameters. Results are described as mean values and standard deviations. Note: Mean changes in MBL for epicrestal and subcrestal placements at lingual and buccal sites is also referred to as "mid-facial bone levels". To determine MBL changes between T0 and each follow-up visit, MBLs at T0 were subtracted from the complementary values for that implant at T18 and T30.
Time Frame
Implant placement, and 18 months and 30 months after implant placement
Secondary Outcome Measure Information:
Title
Change in Mid-Buccal Soft Tissue Height
Description
Soft tissue levels were measured clinically from a fixed reference point to the mid buccal soft tissue margin using a stent. Measurements were made from fixed reference points, by using a stent to perform clinical measurements in a reproducible position.
Time Frame
From final restoration (6 months after implant placement), and 12 months, 18 months, 30 months, 42 months, 54 months, and 66 months after implant placement
Title
Change of Interproximal Levels After Final Restoration
Description
Analysis of interproximal bone height change measured by periapical radiographs. The height of the papilla will be assessed at the mesial and distal sites of the implants, by means of the published "papilla Jemt index". Measurements will be assessed by reviewing the clinical photographs. Reference: Jemt, T. (1997) "Regeneration of gingival papillae after single-implant treatment". International Journal of Periodontics and Restorative Dentistry 17: 326-333.
Time Frame
From final restoration (6 months after implant placement), and 18 months, 30 months, 42 months, 54 months, and 66 months after implant placement
Title
Change in Marginal Bone Level (MBL)
Description
Changes in MBLs at 66 months after implant placement were chosen as a secondary outcome parameter. Results are described as mean values and standard deviations. Note: Mean changes in MBL for epicrestal and subcrestal placements at lingual and buccal sites is also referred to as "mid-facial bone levels". To determine MBL changes between T0 and each follow-up visit, MBLs at T0 were subtracted from the complementary values for that implant at T18, T30 and T66.
Time Frame
Implant placement, and 66 months after implant placement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects must have read, understood and signed an informed consent form; Subjects must be 18 to 70 years of age; Subjects must be able and willing to follow study procedures and instructions; Subjects must have indication to receive two implants in a bilateral maxillary or mandibular edentulous areas (for at least 4 months post extraction) in areas of pre-molars (first or second) and molars (first or second); Sufficient width and height of bone to place at least 8mm length and any compatible in diameter Ankylos implant; Sufficient vertical clearance to place a single tooth crown replacement; No apical disorder/inflammation at the area of the implant site. Exclusion Criteria: Subjects participating in other clinical studies within 1 month prior to screening and/or involving therapeutic intervention (either medical or dental) that could affect bone or soft tissue healing; Female subjects who are pregnant or lactating, or who intend to become pregnant during the study period following entrance into the study; Subjects with parafunctional habits; Subjects who have failed to maintain good plaque control; Subjects with any systemic condition like uncontrolled diabetes mellitus, cancer, HIV, disorders that compromise wound healing, chronic high dose steroid therapy, bone metabolic diseases, radiation or other immuno-suppressive therapy which would preclude periodontal surgery; Absence of occlusal stability in centric occlusion; Subjects with the presence of acute infectious lesions in the areas intended for surgery; History within the last 3 months of weekly or more frequent use of smokeless chewing tobacco, pipe or cigar smoking and cigarette smoking (greater than 10 cigarettes per day) Present alcohol or drug abuse; Angulation requirements of the restoration exceeding approximately 15 degrees; Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration (e.g. calcium channel blocker, dilantin).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart J Froum, DDS
Organizational Affiliation
Bluestone Center for Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bluestone Center for Clinical Research
City
New York
State/Province
New York
ZIP/Postal Code
10010-4086
Country
United States

12. IPD Sharing Statement

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