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

Phase 4

Completed

• Conditions: Immediate Dental Implant
• Interventions: Device: immediate dental implant; Drug: Hyaluronic Acid

• Registration Number: NCT03691467
• Lead Sponsor: Ibrahim Samy Kalboush

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.

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 Timeline

• Study First Submitted: 2018-09-28
• Study First Submitted QC: 2018-09-28
• Study First Posted: 2018-10-01
• Study Start: 2019-09-30
• Primary Completion: 2021-01-12
• Study Completion: 2021-05-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-05
• Last Update Posted: 2021-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
immediate implant with hyaluronic acid.	immediate dental implant	immediate dental implant with topical application of hyaluronic acid.
immediate implant with hyaluronic acid.	Hyaluronic Acid	immediate dental implant with topical application of hyaluronic acid.
immediate implant.	immediate dental implant	immediate dental implant placement with placebo gel

Primary Outcome Measures

Name	Time	Method
implant stability	6 months	implant stability using osstell "implant stability quotient (ISQ)"

Secondary Outcome Measures

Name	Time	Method
soft tissue healing	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).
post operative pain	0-2 and 7 days	assessment of pain severity with 10 point visual analogue scale (VAS) no pain '0' to severe/unbearable pain '10'

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt