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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03691467
Recruitment Status : Active, not recruiting
First Posted : October 1, 2018
Last Update Posted : January 31, 2020
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Ibrahim Samy Kalboush, Cairo University

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
Immediate Dental Implant 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized clinical trial
Masking: Double (Participant, Investigator)
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 : September 30, 2019
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


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 Name: post extraction dental implant

Drug: Hyaluronic Acid
topical application of hyaluronic acid
Other Name: gengigel

Active Comparator: immediate implant.
immediate dental implant placement.
Device: immediate dental implant
immediate dental implant placement in freshly extracted socket.
Other Name: post extraction dental implant




Primary Outcome Measures :
  1. implant stability [ Time Frame: 6 months ]
    implant stability using osstel "implant stability quotient (ISQ)"


Secondary Outcome Measures :
  1. soft tissue healing [ Time Frame: 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 [ Time Frame: 7 ays ]
    assessment of pain severity with 10 point visual analogue scale (VAS) no pain '0' to severe/unbearable pain '10'



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT03691467


Locations
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Egypt
Cairo University
Cairo, Egypt
Sponsors and Collaborators
Ibrahim Samy Kalboush
Cairo University
Investigators
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Study Chair: Mona shoeib, Doctor's Cairo University
Study Chair: Mona Darhous, Doctor's Cairo University

Publications:
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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: October 1, 2018    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: i will check with my study chair

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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, Cairo University:
immediate dental implant
immediate implant
hyaluronic acid
gengigel
Additional relevant MeSH terms:
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Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents