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

NCT05776290 | Completed DMC

• 1 other identifier: UDDS-OralMed-01-2023
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Implant Complication

Outcome Measures

Primary Outcomes (1)

• Change in the Perception of pain

  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

Study Arms (2)

Hyaluronic acid injection

EXPERIMENTAL

The hyaluronic acid will be injected into the implant socket before implantation.

Biological: Hyaluronic Acid

Traditional treatment

NO INTERVENTION

The socket will be prepared in the normal manner without being injected with any material.

Interventions

Hyaluronic Acid BIOLOGICAL

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.

Hyaluronic acid injection

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Oral Medicine, Faculty of Dentistry, University of Damascus

Damascus, DM20AM19, Syria

Location

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Waseem Al-Khateeb, DDS MSc

  PhD student at the Department of Oral Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split mouth design

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 20, 2023
• Study Start: February 15, 2021
• Primary Completion: March 15, 2022
• Study Completion: May 15, 2022
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)