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Clinical and Radiographic Evaluation of the Effect of Hyaluronic Acid Surface Treatment Versus Sandblasted Acid Etched on Stability of Delayed Dental Implant in Posterior Maxilla.

Primary Purpose

Missing Teeth, Bone Loss

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hyaluronic acid
sandblasted, and acid-etched
Delayed dental implant
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Missing Teeth focused on measuring Dental implant, Stability, Osseointegration, Hyaluronic acid, Sandblasted acid etched

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients with missing teeth in posterior maxilla. Both genders males and females will be included. Age from 18-60 years. Exclusion Criteria: General contraindications to implant surgery. Subjected to irradiation in the head and neck area less than 1 year before implantation. Untreated periodontitis. Poor oral hygiene and motivation. Uncontrolled diabetes. Pregnant or nursing. Substance abuse. Psychiatric problems or unrealistic expectations. Severe bruxism or clenching. Immunosuppressed or immunocompromised. Treated or under treatment with intravenous amino-bisphosphonates. Active infection or severe inflammation in the area intended for implant placement. Unable to open mouth sufficiently to accommodate the surgical tooling. Patients participating in other studies, if the present protocol could not be properly followed.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Hyaluronic acids

    Sandblasting acid etched

    Arm Description

    Hyaluronic acid has a huge potential to speed up the healing process and increase implant stability by enhancing bone/implant interaction and new bone formation.

    Sandblasting and acid etching is the most commonly used basic method for modifying the surface of dental implants . the sandblasting procedure "roughs up" the outer layer of the implant , creating a surface that is easier for the bone to grip as the implant heals.

    Outcomes

    Primary Outcome Measures

    Implant stability
    It is assessed by using Osstell To determine the stability after intervention scale from 60 to 70 ISQ 60 low stability 70 high stability .

    Secondary Outcome Measures

    soft tissue healing
    It is assessed by using gingival index in Clinical examination scale from 0 Normal 1 Mild inflammation 2 Moderate inflammation 3 Severe inflammation .
    bone density
    It is assessed by using CBCT To determine the density of bone after intervention

    Full Information

    First Posted
    September 5, 2023
    Last Updated
    September 11, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06033989
    Brief Title
    Clinical and Radiographic Evaluation of the Effect of Hyaluronic Acid Surface Treatment Versus Sandblasted Acid Etched on Stability of Delayed Dental Implant in Posterior Maxilla.
    Official Title
    Clinical and Radiographic Evaluation of the Effect of Hyaluronic Acid Surface Treatment Versus Sandblasted Acid Etched Surface Treatment on Stability of Delayed Dental Implant in Posterior Maxilla. Comparative Randomized Clinical Trial (RCT).
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    August 1, 2024 (Anticipated)
    Study Completion Date
    January 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Clinical and Radiographic Evaluation of the Effect of Hyaluronic Acid Surface Treatment Versus Sandblasted Acid Etched on Stability of Delayed Dental Implant in Posterior Maxilla.
    Detailed Description
    A dental implant is one of the procedures to restore missing teeth , to achieved the stability for implant success is the direct growth of bone to the implant surface, known as Osseointegration.As a result, bone stability around dental implants is determined by factors that the implantologist may or may not directly influence, such as local bone quality and bone metabolism, as well as systemic factors such as age, systematic chronic diseases and lifestyle (e.g., smoking habits).Treatment-related factors include augmentation material, implant design (macro and micro), surgical procedures, and loading protocols. Therefore , it may be needed for a surface treatment could alter the topography, chemical content, and roughness of the surface and result in various biological reactions. The surface treatment can also increase the area of contact between the implant and the supporting bone . The rationale is evaluate Increasing the implant stability around implants placed by using hyaluronic acid that act to improving the connection between implant and bone .Sandblasting and acid etching is the most commonly used basic method for modifying the surface of dental implants . the sandblasting procedure "roughs up" the outer layer of the implant,creating a surface that is easier for the bone to grip as the implant heals.While hyaluronic acid and its derivatives have a strong chance of osseointegration and mineralization and have been utilized extensively for bone repair.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Missing Teeth, Bone Loss
    Keywords
    Dental implant, Stability, Osseointegration, Hyaluronic acid, Sandblasted acid etched

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hyaluronic acids
    Arm Type
    Experimental
    Arm Description
    Hyaluronic acid has a huge potential to speed up the healing process and increase implant stability by enhancing bone/implant interaction and new bone formation.
    Arm Title
    Sandblasting acid etched
    Arm Type
    Active Comparator
    Arm Description
    Sandblasting and acid etching is the most commonly used basic method for modifying the surface of dental implants . the sandblasting procedure "roughs up" the outer layer of the implant , creating a surface that is easier for the bone to grip as the implant heals.
    Intervention Type
    Drug
    Intervention Name(s)
    Hyaluronic acid
    Intervention Description
    Delayed dental implant placement after application of surface treatment to enhance Osseointegration and healing .
    Intervention Type
    Drug
    Intervention Name(s)
    sandblasted, and acid-etched
    Intervention Description
    Delayed dental implant placement after application of surface treatment to enhance Osseointegration and healing .
    Intervention Type
    Procedure
    Intervention Name(s)
    Delayed dental implant
    Intervention Description
    Surgical procedure of delayed dental implant in posterior maxilla after application of surface treatment to enhance Osseointegration and healing .
    Primary Outcome Measure Information:
    Title
    Implant stability
    Description
    It is assessed by using Osstell To determine the stability after intervention scale from 60 to 70 ISQ 60 low stability 70 high stability .
    Time Frame
    0-3 months
    Secondary Outcome Measure Information:
    Title
    soft tissue healing
    Description
    It is assessed by using gingival index in Clinical examination scale from 0 Normal 1 Mild inflammation 2 Moderate inflammation 3 Severe inflammation .
    Time Frame
    10 days
    Title
    bone density
    Description
    It is assessed by using CBCT To determine the density of bone after intervention
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with missing teeth in posterior maxilla. Both genders males and females will be included. Age from 18-60 years. Exclusion Criteria: General contraindications to implant surgery. Subjected to irradiation in the head and neck area less than 1 year before implantation. Untreated periodontitis. Poor oral hygiene and motivation. Uncontrolled diabetes. Pregnant or nursing. Substance abuse. Psychiatric problems or unrealistic expectations. Severe bruxism or clenching. Immunosuppressed or immunocompromised. Treated or under treatment with intravenous amino-bisphosphonates. Active infection or severe inflammation in the area intended for implant placement. Unable to open mouth sufficiently to accommodate the surgical tooling. Patients participating in other studies, if the present protocol could not be properly followed.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shihanah Alkashi, BSc
    Phone
    00966542044424
    Email
    Shihanah.yousef@dentistry.cu.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    22567435
    Citation
    Peck MT, Marnewick J, Stephen L. Alveolar ridge preservation using leukocyte and platelet-rich fibrin: a report of a case. Case Rep Dent. 2011;2011:345048. doi: 10.1155/2011/345048. Epub 2011 Jul 3.
    Results Reference
    background
    PubMed Identifier
    9922740
    Citation
    Meredith N. Assessment of implant stability as a prognostic determinant. Int J Prosthodont. 1998 Sep-Oct;11(5):491-501.
    Results Reference
    background
    PubMed Identifier
    32230917
    Citation
    Velasco-Ortega E, Jimenez-Guerra A, Monsalve-Guil L, Ortiz-Garcia I, Nicolas-Silvente AI, Segura-Egea JJ, Lopez-Lopez J. Long-Term Clinical Outcomes of Treatment with Dental Implants with Acid Etched Surface. Materials (Basel). 2020 Mar 27;13(7):1553. doi: 10.3390/ma13071553.
    Results Reference
    background
    PubMed Identifier
    15348583
    Citation
    Massaro C, Rotolo P, De Riccardis F, Milella E, Napoli A, Wieland M, Textor M, Spencer ND, Brunette DM. Comparative investigation of the surface properties of commercial titanium dental implants. Part I: chemical composition. J Mater Sci Mater Med. 2002 Jun;13(6):535-48. doi: 10.1023/a:1015170625506.
    Results Reference
    background
    PubMed Identifier
    33925742
    Citation
    Cervino G, Meto A, Fiorillo L, Odorici A, Meto A, D'Amico C, Oteri G, Cicciu M. Surface Treatment of the Dental Implant with Hyaluronic Acid: An Overview of Recent Data. Int J Environ Res Public Health. 2021 Apr 27;18(9):4670. doi: 10.3390/ijerph18094670.
    Results Reference
    background
    PubMed Identifier
    29262027
    Citation
    Gupta R, Gupta N, Weber, DDS KK. Dental Implants. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470448/
    Results Reference
    result

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    Clinical and Radiographic Evaluation of the Effect of Hyaluronic Acid Surface Treatment Versus Sandblasted Acid Etched on Stability of Delayed Dental Implant in Posterior Maxilla.

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