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Clinical Trials/NCT03691467
NCT03691467CompletedPhase 4

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

Ibrahim Samy Kalboush1 site in 1 country24 target enrollmentStarted: September 30, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
24
Locations
1
Primary Endpoint
implant stability

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Masking Description

by addition of placebo gel in the control group

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
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.

Arms & Interventions

immediate implant with hyaluronic acid.

Experimental

immediate dental implant with topical application of hyaluronic acid.

Intervention: immediate dental implant (Device)

immediate implant with hyaluronic acid.

Experimental

immediate dental implant with topical application of hyaluronic acid.

Intervention: Hyaluronic Acid (Drug)

immediate implant.

Active Comparator

immediate dental implant placement with placebo gel

Intervention: immediate dental implant (Device)

Outcomes

Primary Outcomes

implant stability

Time Frame: 6 months

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

Secondary Outcomes

  • soft tissue healing(10 days)
  • post operative pain(0-2 and 7 days)

Investigators

Sponsor
Ibrahim Samy Kalboush
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Ibrahim Samy Kalboush

Associate lecturer in periodontology and oral medicine department Delta University

Cairo University

Study Sites (1)

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