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Completed

NCT Number: NCT03691467

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

immediate dental implant

Device

immediate dental implant placement in freshly extracted socket.

Other names: post extraction dental implant

Hyaluronic acid

Drug

topical application of hyaluronic acid

Other names: gengigel

Primary outcomes

  1. implant stability

    Time frame: 6 months

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

Secondary outcomes

  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: 0-2 and 7 days

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

Sponsors and collaborators

Lead sponsor

Ibrahim Samy Kalboush

Other

Collaborators

  • Cairo University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 1, 2018
Registry last updated
Jun 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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