The Effect of Hyaluronic Acid Gel on Relieving Post-Implantation Pain

April 5, 2023 updated by: Damascus University

Evaluation of the Efficacy of a Hyaluronic Acid Gel in Relieving Post-Implantation Pain: A Split-Mouth Randomized Controlled Trial

Few previous studies have employed HA in the implant socket; instead, the majority have applied it topically to the area around dental implants after they have been placed. The application was done after suturing in these investigations. Therefore, the goal of the current study was to inject HA into the implant socket and onto the alveolar bone prior to implant insertion and suturing in order to preserve the HA for an extended period of time.

This study aims to use a visual analog scale (VAS) on the first, third, and tenth days following the surgical intervention to assess the efficacy of employing HA in dental implants in terms of pain reduction that may accompany dental implant surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

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 Locations

  • Syrian Arab Republic
      • Damascus, Syrian Arab Republic, DM20AM19
        • Department of Oral Medicine, Faculty of Dentistry, University of Damascus

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

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • bilateral tooth loss with a sufficient amount of bone volume
  • no general problems
  • good oral health
  • age between 20 and 60 years

Exclusion Criteria:

  • the use of immunosuppressive drugs and corticosteroids for long periods
  • the existence of serious systemic disorders
  • contraindications for local anesthesia or oral surgery
  • pregnant women and nursing mothers
  • patients receiving chemotherapy or radiation
  • alcoholics and heavy smokers.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyaluronic acid injection
The hyaluronic acid will be injected into the implant socket before implantation.
Biological: Hyaluronic Acid
This material will be injected into the prepared impact socket prior to inserting the implant. This injection will be done inside the socket as well as on the periphery of the socket.
No Intervention: Traditional treatment
The socket will be prepared in the normal manner without being injected with any material.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Perception of pain
Time Frame: First assessment: at 24 hours following the surgical procedure. Second assessment: at 72 hours following the surgical intervention. Third assessment will be made on the tenth day following the surgical intervention
This will be measured using a numeric rating scale. Patients will be asked to indicate the level of pain they perceive on a scale from 1 to 10. The intensity of pain is going to be classified according to the following categories: 0 = no pain, 1-3 = mild pain, 3-6 = moderate pain, and 6-10 = severe pain.
First assessment: at 24 hours following the surgical procedure. Second assessment: at 72 hours following the surgical intervention. Third assessment will be made on the tenth day following the surgical intervention

Collaborators and Investigators

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

Sponsor

Damascus University

Investigators

  • Principal Investigator: Waseem Al-Khateeb, DDS MSc, PhD student at the Department of Oral Medicine

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 (Actual)

February 15, 2021

Primary Completion (Actual)

March 15, 2022

Study Completion (Actual)

May 15, 2022

Study Registration Dates

First Submitted

March 8, 2023

First Submitted That Met QC Criteria

March 8, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 5, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-OralMed-01-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Datasets and the underlying worksheets are available upon reasonable request from the corresponding author once the paper has been published.

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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