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Clinical Evaluation of Vertical Inter-implant Papilla Height in Platform Matched Implants in Comparison to Morse Connection Abutments

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ClinicalTrials.gov Identifier: NCT03787355
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Nada Zazou, Cairo University

Brief Summary:

The complete fill of the inter-implant mucosa is much more challenging between two implants, than single implants, and is considered to be unpredictable (Tymstra et al., 2011). However, previous clinical studies have pointed to a relationship between the inter-implant mucosa fill and the horizontal distance between two adjacent implants. In particular, a greater inter-implant bone loss and the absence of the inter-implant mucosa were noted when neighboring implants were not separated by more than 3 mm (Tarnow, Magner and Fletcher, 1992).

The implant-abutment connection may have an impact on the amount such inter-implant bone loss, with morse-taper (MT) abutments emerging from the central region of the implant allow additional thickness in the horizontal soft-tissue component. This might help reducing marginal bone remodeling during biological width formation. Moreover, the literature indicates that the peri-implant bone strain vary significantly with the type of implant-abutment connection. The conical interface of MT connections helps dissipating the forces to the fixture.

The aim of the study is to clinically investigate the fate of soft tissue and papilla following crown placement on neighboring morse cone implants versus non-platform switched implants denoting the fate of soft tissue and papilla.


Condition or disease Intervention/treatment Phase
Interimplant Mucosa Combination Product: Morse connection Implants Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention versus Control.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Vertical Inter-implant Papilla Height in Platform Matched Implants in Comparison to Morse Connection Abutments: A Randomized Controlled Clinical Trial
Estimated Study Start Date : February 17, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Arm Intervention/treatment
Experimental: Cone Morse Connection Implants
2 neighboring Morse connection Implants
Combination Product: Morse connection Implants
2 neighboring morse connection Implants of Zinedent - Strauman

Active Comparator: platform matched implants
2 neighboring platform matched implants.
Combination Product: Morse connection Implants
2 neighboring morse connection Implants of Zinedent - Strauman




Primary Outcome Measures :
  1. Vertical papilla height [ Time Frame: 6,12 months from T0 (Implant insertion) ]
    Change will be measured using periodontal probe in millimeters,


Secondary Outcome Measures :
  1. Pink esthetic score (PES) [ Time Frame: 12 months from T0 (Implant insertion) ]
    Numerical Rating Score (Fürhauser et al, 2005)

  2. Crestal bone resorption [ Time Frame: T0 at the time of implant insertion, T1 at 3 months after implant insertion and at T3 at 12 months after implant insertion. ]
    Using digital X-ray, bone resorption will be measured using a software in mm.

  3. Probing depth (PD) [ Time Frame: 3, 6,12 months from T0 (Implant insertion) ]
    six sites of each implant (mesiobuccal, buccal, distobuccal, distolingual, lingual, and mesiolingual)

  4. Bleeding on probing (BOP) [ Time Frame: at T2 (6 months after implant insertion) and T3 (12 months after Implant Insertion). ]
    Binary, Using periodontal probe.

  5. Width of buccal keratinized mucosa (KM) [ Time Frame: 3, 6,12 months from T0 (Implant insertion) ]
    Measured at the midbuccal surface of each implant using periodontal probe in mm.

  6. Patient satisfaction (cleaning, food impaction) [ Time Frame: At T2 (6 months after implant insertion) and T3 (12 months after Implant Insertion). ]
    Measured using Numerical Rating Scale (NRS) (Kiyak et al, 1984)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Systemically healthy patients.
  • Good oral hygiene.
  • Missing minimum of two neighboring maxillary teeth with sufficient bucco-palatal bone of ≥ 6mm.
  • Interimplant distance planned to be 3-4 mm.
  • Patient acceptance of more than one year of follow up.

Exclusion Criteria:

  • Vertically deficient ridges. (≤10 mm)
  • Smokers.
  • Pregnant females.
  • Thin biotype

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787355


Contacts
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Contact: Nada Zazou, Masters 02-01224016945 drzazou@hotmail.com

Locations
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Egypt
Cairo University Recruiting
Cairo, Egypt, 12613
Contact: Nada Zazou, Masters         
Sponsors and Collaborators
Cairo University

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Responsible Party: Nada Zazou, Principle Investigator, assistant Lecturer, Modern Sciences and Arts University (MSA)., Cairo University
ClinicalTrials.gov Identifier: NCT03787355     History of Changes
Other Study ID Numbers: PERIO7:4:85
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No