the Effect of Topical Application of Hyaluronic Acid on Immediate Dental Implant

Sponsor
Ibrahim Samy Kalboush (Other)
Overall Status
Completed
CT.gov ID
NCT03691467
Collaborator
Cairo University (Other)
24
1
2
20
1.2

Study Details

Study Description

Brief Summary

The high predictability of immediate dental implants has led to routine use with a great expectation for success.

Immediate implant placement in fresh extraction sockets was reported to reduce alveolar bone resorption, Better esthetic outcomes were achieved including the prosthetic crown length in harmony with the adjacent teeth, natural scalloping and easier distinct papillae to achieve and maximum soft tissue support.

hyaluronic acid can be placed in freshly extracted sockets immediately after tooth extraction , also it could be used on implant surface in which hyaluronic acid enhance new bone formation around dental implants.

Condition or Disease Intervention/Treatment Phase
  • Device: immediate dental implant
  • Drug: Hyaluronic Acid
Phase 4

Detailed Description

Immediate dental implant placement was introduced more than 30 years ago by Schulte and Heimke in 1976.

The major advantages of immediate implant placement are reduction in number of visits, thus reduces the treatment time and improves patient satisfaction, provides ideal three dimensional implant position, and preserves the alveolar bone in the extraction socket

. However, immediate implants may have some disadvantages that can affect the success rate, which include inadequate primary implant stability when compared with delayed implants, inadequate soft tissue closure especially in case of thin tissue biotype, inability to inspect all aspects of the extraction site for defects or infection, and finally the added cost of bone grafting when the jumping distance is over 2mm.

Hyaluronic acid (HA) is one of the extracellular components of the connective tissue that belongs to the family of glycosaminoglycans, due to its non-immunogenic and non-toxic properties , it can be used in many medical fields such as dentistry, ophthalmology, dermatology.

HA has an important role in wound healing through inducing early granulation tissue formation, inhibiting destructive inflammatory process during the process of tissue healing, inducing re-epithelialization and angiogenesis.

HA not only acted as a carrier of growth factors and cells but also stimulated bone formation through chemotaxis, proliferation and differentiation of mesenchymal cells into osteoblasts. Although HA shares bone induction properties with osteogenic growth factors as bone morphogenic protein 2 and osteopontin.

HA also has anti-inflammatory effect through scavenging reactive oxygen species, such as superoxide radical (O2) and hydroxyl radical (OH) species, and inhibiting neutrophil derived serine proteinases, HA also has anti-edematous effect that may be related to its osmotic buffering capacity.

So surrounding of an implant with hyaluronic acid give a great potential to improve new bone formation and improve bone/implant contact which will improve healing time and implant stability.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized clinical trialrandomized clinical trial
Masking:
Double (Participant, Investigator)
Masking Description:
by addition of placebo gel in the control group
Primary Purpose:
Treatment
Official Title:
The Effect of Hyaluronic Acid on Implant Stability After Immediate Implant Placement in Anterior and Premolar Region in Systemically Healthy Patients
Actual Study Start Date :
Sep 30, 2019
Actual Primary Completion Date :
Jan 12, 2021
Actual Study Completion Date :
May 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: immediate implant with hyaluronic acid.

immediate dental implant with topical application of hyaluronic acid.

Device: immediate dental implant
immediate dental implant placement in freshly extracted socket.
Other Names:
  • post extraction dental implant
  • Drug: Hyaluronic Acid
    topical application of hyaluronic acid
    Other Names:
  • gengigel
  • Active Comparator: immediate implant.

    immediate dental implant placement with placebo gel

    Device: immediate dental implant
    immediate dental implant placement in freshly extracted socket.
    Other Names:
  • post extraction dental implant
  • Outcome Measures

    Primary Outcome Measures

    1. implant stability [6 months]

      implant stability using osstell "implant stability quotient (ISQ)"

    Secondary Outcome Measures

    1. soft tissue healing [10 days]

      assessment of soft tissue healing using likert scale from (0-4) with 0: Complete wound closure without presence of fibrin and 4:Incomplete wound closure (necrosis).

    2. post operative pain [0-2 and 7 days]

      assessment of pain severity with 10 point visual analogue scale (VAS) no pain '0' to severe/unbearable pain '10'

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Systemically healthy patients indicated for single or multiple immediate implants in anterior and premolar region. Absence of any peri-apical pathosis. Patients with intact buccal plate of bone. Patients with adequate bone volume for the dental implant procedure. Patient consent approval and signing.
    Exclusion Criteria:
    • Smokers. Systemic disease that may affect the final outcome of the surgical procedure. No or poor patient's compliance. Patients with psychological problems. Pathology at the site of intervention. Pregnant patients. Patients refuse to sign an informed consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo University Cairo Egypt

    Sponsors and Collaborators

    • Ibrahim Samy Kalboush
    • Cairo University

    Investigators

    • Study Chair: Mona shoeib, Doctor's, Cairo University
    • Study Chair: Mona Darhous, Doctor's, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ibrahim Samy Kalboush, Associate lecturer in periodontology and oral medicine department Delta University, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03691467
    Other Study ID Numbers:
    • perio1088
    First Posted:
    Oct 1, 2018
    Last Update Posted:
    Jun 8, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Ibrahim Samy Kalboush, Associate lecturer in periodontology and oral medicine department Delta University, Cairo University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 8, 2021