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

NCT01759537 | Completed Results

• 1 other identifier: Ankylos-Bluestone
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Mouth, Edentulous

Outcome Measures

Primary Outcomes (1)

• 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.

  Implant placement, and 18 months and 30 months after implant placement

Secondary Outcomes (3)

• Change in Mid-Buccal Soft Tissue Height

  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

• Change of Interproximal Levels After Final Restoration

  From final restoration (6 months after implant placement), and 18 months, 30 months, 42 months, 54 months, and 66 months after implant placement

• Change in Marginal Bone Level (MBL)

  Implant placement, and 66 months after implant placement

Study Arms (2)

Implants placed at sub-crestal position.

EXPERIMENTAL

Ankylos dental endosseous implants-Sub-crestal

Device: Ankylos dental endosseous implants-Sub-crestal

Epi-crestal implants.

ACTIVE COMPARATOR

Ankylos dental endosseous implants-Epi-crestal

Device: Ankylos dental endosseous implants-Epi-crestal

Interventions

Ankylos dental endosseous implants-Sub-crestal DEVICE

Implants placed subcrestally

Implants placed at sub-crestal position.

Ankylos dental endosseous implants-Epi-crestal DEVICE

Implants placed Epi-crestally

Epi-crestal implants.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dentsply International: lead

Study Sites (1)

Bluestone Center for Clinical Research

New York, New York, 10010-4086, United States

Location

Related Links

• Bluestone Clinic at NYU

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Limitations and Caveats

Several limitations within the present study should be noted with regard to: 1) CT scan performance, 2) intraoral radiograph outcomes, 3) soft tissue level outcomes, 4) periodontal and peri-implant status, and 5) restorative procedures.

Results Point of Contact

• Title: Ismael Khouly
• Organization: NYU College of Dentistry

iek3@nyu.edu

212-998-9800

Study Officials

• Stuart J Froum, DDS

  Bluestone Center for Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This was a split mouth study design in which the same patient was used for both arms.

Study Record Dates

• First Submitted: December 31, 2012
• First Posted: January 3, 2013
• Study Start: April 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2019
• Last Updated: December 29, 2022
• Results First Posted: December 29, 2022

Record last verified: 2022-12

Locations

US (1)