Clinical and Radiographic Evaluation of the Effect of Hyaluronic Acid Surface Treatment Versus Sandblasted Acid Etched on Stability of Delayed Dental Implant in Posterior Maxilla.

September 11, 2023 updated by: Shihanah Yousef Ahmed Alkashi, Cairo University

Clinical and Radiographic Evaluation of the Effect of Hyaluronic Acid Surface Treatment Versus Sandblasted Acid Etched Surface Treatment on Stability of Delayed Dental Implant in Posterior Maxilla. Comparative Randomized Clinical Trial (RCT).

Clinical and Radiographic Evaluation of the Effect of Hyaluronic Acid Surface Treatment Versus Sandblasted Acid Etched on Stability of Delayed Dental Implant in Posterior Maxilla.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

A dental implant is one of the procedures to restore missing teeth , to achieved the stability for implant success is the direct growth of bone to the implant surface, known as Osseointegration.As a result, bone stability around dental implants is determined by factors that the implantologist may or may not directly influence, such as local bone quality and bone metabolism, as well as systemic factors such as age, systematic chronic diseases and lifestyle (e.g., smoking habits).Treatment-related factors include augmentation material, implant design (macro and micro), surgical procedures, and loading protocols. Therefore , it may be needed for a surface treatment could alter the topography, chemical content, and roughness of the surface and result in various biological reactions. The surface treatment can also increase the area of contact between the implant and the supporting bone . The rationale is evaluate Increasing the implant stability around implants placed by using hyaluronic acid that act to improving the connection between implant and bone .Sandblasting and acid etching is the most commonly used basic method for modifying the surface of dental implants . the sandblasting procedure "roughs up" the outer layer of the implant,creating a surface that is easier for the bone to grip as the implant heals.While hyaluronic acid and its derivatives have a strong chance of osseointegration and mineralization and have been utilized extensively for bone repair.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with missing teeth in posterior maxilla.
  • Both genders males and females will be included.
  • Age from 18-60 years.

Exclusion Criteria:

  • General contraindications to implant surgery.
  • Subjected to irradiation in the head and neck area less than 1 year before implantation.
  • Untreated periodontitis.
  • Poor oral hygiene and motivation.
  • Uncontrolled diabetes.
  • Pregnant or nursing.
  • Substance abuse.
  • Psychiatric problems or unrealistic expectations.
  • Severe bruxism or clenching.
  • Immunosuppressed or immunocompromised.
  • Treated or under treatment with intravenous amino-bisphosphonates.
  • Active infection or severe inflammation in the area intended for implant placement.
  • Unable to open mouth sufficiently to accommodate the surgical tooling.
  • Patients participating in other studies, if the present protocol could not be properly followed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyaluronic acids
Hyaluronic acid has a huge potential to speed up the healing process and increase implant stability by enhancing bone/implant interaction and new bone formation.
Drug: Hyaluronic acid
Delayed dental implant placement after application of surface treatment to enhance Osseointegration and healing .
Procedure: Delayed dental implant
Surgical procedure of delayed dental implant in posterior maxilla after application of surface treatment to enhance Osseointegration and healing .
Active Comparator: Sandblasting acid etched
Sandblasting and acid etching is the most commonly used basic method for modifying the surface of dental implants . the sandblasting procedure "roughs up" the outer layer of the implant , creating a surface that is easier for the bone to grip as the implant heals.
Procedure: Delayed dental implant
Surgical procedure of delayed dental implant in posterior maxilla after application of surface treatment to enhance Osseointegration and healing .
Drug: sandblasted, and acid-etched
Delayed dental implant placement after application of surface treatment to enhance Osseointegration and healing .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant stability
Time Frame: 0-3 months
It is assessed by using Osstell To determine the stability after intervention scale from 60 to 70 ISQ 60 low stability 70 high stability .
0-3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
soft tissue healing
Time Frame: 10 days
It is assessed by using gingival index in Clinical examination scale from 0 Normal 1 Mild inflammation 2 Moderate inflammation 3 Severe inflammation .
10 days
bone density
Time Frame: 3 months
It is assessed by using CBCT To determine the density of bone after intervention
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 11, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shihanah1993

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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