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

June 5, 2021 updated by: Ibrahim Samy Kalboush

The Effect of Hyaluronic Acid on Implant Stability After Immediate Implant Placement in Anterior and Premolar Region in Systemically Healthy Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
implant stability
Time Frame: 6 months
implant stability using osstell "implant stability quotient (ISQ)"
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
10 days
post operative pain
Time Frame: 0-2 and 7 days
assessment of pain severity with 10 point visual analogue scale (VAS) no pain '0' to severe/unbearable pain '10'
0-2 and 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ibrahim Samy Kalboush

Collaborators

Cairo University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2019

Primary Completion (Actual)

January 12, 2021

Study Completion (Actual)

May 30, 2021

Study Registration Dates

First Submitted

September 28, 2018

First Submitted That Met QC Criteria

September 28, 2018

First Posted (Actual)

October 1, 2018

Study Record Updates

Last Update Posted (Actual)

June 8, 2021

Last Update Submitted That Met QC Criteria

June 5, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • perio1088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

i will check with my study chair

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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