NCT03691467

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
12 months until next milestone

Study Start

First participant enrolled

September 30, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

1.3 years

First QC Date

September 28, 2018

Last Update Submit

June 5, 2021

Conditions

Immediate Dental Implant

Keywords

immediate dental implantimmediate implanthyaluronic acidgengigel

Outcome Measures

Primary Outcomes (1)

  • implant stability

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

    6 months

Secondary Outcomes (2)

  • soft tissue healing

    10 days

  • post operative pain

    0-2 and 7 days

Study Arms (2)

immediate implant with hyaluronic acid.

EXPERIMENTAL

immediate dental implant with topical application of hyaluronic acid.

Device: immediate dental implantDrug: Hyaluronic Acid

immediate implant.

ACTIVE COMPARATOR

immediate dental implant placement with placebo gel

Device: immediate dental implant

Interventions

immediate dental implantDEVICE

immediate dental implant placement in freshly extracted socket.

Also known as: post extraction dental implant
immediate implant with hyaluronic acid.immediate implant.
Hyaluronic AcidDRUG

topical application of hyaluronic acid

Also known as: gengigel
immediate implant with hyaluronic acid.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 24113890BACKGROUND

  • 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.

    PMID: 24928668BACKGROUND

MeSH Terms

Interventions

Immediate Dental Implant LoadingHyaluronic Acid

Intervention Hierarchy (Ancestors)

Dental Implantation, EndosseousDental ImplantationOral Surgical Procedures, PreprostheticOral Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationDentistryProsthodonticsGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Mona shoeib, Doctor's

    Cairo University

    STUDY CHAIR

  • Mona Darhous, Doctor's

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
by addition of placebo gel in the control group
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate lecturer in periodontology and oral medicine department Delta University

Study Record Dates

First Submitted

September 28, 2018

First Posted

October 1, 2018

Study Start

September 30, 2019

Primary Completion

January 12, 2021

Study Completion

May 30, 2021

Last Updated

June 8, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

i will check with my study chair

Locations

EG(1)