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CompletedNCT03691467Updated Jun 8, 2021

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

A Phase 4 interventional study of immediate dental implant and Hyaluronic Acid in Immediate Dental Implant, sponsored by Ibrahim Samy Kalboush. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-08.

Sponsored by Ibrahim Samy Kalboush · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jan 2021, 5 years 8 months ago, and no results have been posted to the registry.
Phase
Phase 4
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Immediate Dental Implant

Keywords

  • immediate dental implant
  • immediate implant
  • hyaluronic acid
  • gengigel
03

In context

Lead sponsor

This is the only study on the registry with Ibrahim Samy Kalboush as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    immediate implant with hyaluronic acid.

    immediate dental implant with topical application of hyaluronic acid.

    Device: immediate dental implant · Drug: Hyaluronic Acid

  • Active comparator
    immediate implant.

    immediate dental implant placement with placebo gel

    Device: immediate dental implant

Interventions

  • Deviceimmediate dental implant

    immediate dental implant placement in freshly extracted socket.

    Also known as: post extraction dental implant

  • DrugHyaluronic Acid

    topical application of hyaluronic acid

    Also known as: gengigel

06

What researchers measure

Primary outcomes

  1. implant stability

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

    Time frame: 6 months

Secondary outcomes

  1. soft tissue healing

    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).

    Time frame: 10 days

  2. post operative pain

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

    Time frame: 0-2 and 7 days

07

Study locations

1 site
  • Cairo University
    Cairo, Egypt
08

References and documents

Publications

  • Schulz MC, Korn P, Stadlinger B, Range U, Moller S, Becher J, Schnabelrauch M, Mai R, Scharnweber D, Eckelt U, Hintze V. Coating with artificial matrices from collagen and sulfated hyaluronan influences the osseointegration of dental implants. J Mater Sci Mater Med. 2014 Jan;25(1):247-58. doi: 10.1007/s10856-013-5066-3. Epub 2013 Oct 11. PubMed 24113890 ↗
  • Lee JH, Kim J, Baek HR, Lee KM, Seo JH, Lee HK, Lee AY, Zheng GB, Chang BS, Lee CK. Fabrication of an rhBMP-2 loaded porous beta-TCP microsphere-hyaluronic acid-based powder gel composite and evaluation of implant osseointegration. J Mater Sci Mater Med. 2014 Sep;25(9):2141-51. doi: 10.1007/s10856-014-5250-0. Epub 2014 Jun 14. PubMed 24928668 ↗

Individual participant data

Plan to share: No — i will check with my study chair

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03691467
Lead sponsor
Ibrahim Samy Kalboush
Collaborators
Cairo University
Responsible party
Ibrahim Samy Kalboush (Associate lecturer in periodontology and oral medicine department Delta University, Cairo University) — Sponsor-investigator
First posted
Oct 1, 2018
Start date
Sep 30, 2019
Primary completion
Jan 12, 2021
Completion
May 30, 2021
Last update
Jun 8, 2021

Study contacts

Mona shoeib, Doctor's
study chair · Cairo University
Mona Darhous, Doctor's
study chair · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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