Hyaluronic Acid Gel in Ridge Preservation

Efficacy of Hyaluronic Acid Gel in Ridge Preservation After Tooth Extraction: A Randomized Controlled Clinical Trial With Radiographic and Histomorphometric Study

hyaluronic acid gel applied at the extraction socket after extraction immediately to preserve the socket from post extraction resorption. hyaluronic acid has ability for osteogenesis and new bone formation.

Study Overview

• Status: Completed
• Conditions: Hyaluronic Acid Gel for Preservation the Extraction Socket
• Intervention / Treatment: Drug: Hyaluronic acid; Other: empty socket

Detailed Description

twenty-four patients with one hopeless tooth at least, first CBCt before extraction to evaluate the dimension of the socket, then atraumatic extraction of the tooth to preserve the bony wall of the socket, after extraction and curettage the socket applied hyaluronic acid gel inside the socket and applied collagen membrane to secure the socket. After 4 months of extraction, CBCt was done to evaluate the dimension of the socket and the effect of hyaluronic acid. Furthermore, The core biopsy was taken by trephine bur at the time of implant placement for evaluate the histological appearance of the bone to evaluate the secondary outcome. then after three months the crown was delivered as a prosthetic part.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Healthy adult patients as evidenced by Burkett's oral medicine health history questionnaire
2. Both genders.
3. Age from 20 -50 years old.
4. Having at least one hopeless teeth indicated for extraction.
5. Esthetic zone teeth (anterior or premolar).
6. Sockets type 1 or 2 .

7. Patient should agree to sign a written consent after the nature of the study will be explained.

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   Exclusion Criteria:

1- Smokers. 2- Pregnant and breast-feeding females. 3- Mentally retarded Patients. 4- Prisoners and handicapped patients. 5- Patients with malocclusion.

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Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: hyaluronic acid gel; Hyaluronic acid considers as a high molecular weight glycosaminoglycan (GAG) consists of multiple disaccharide non-sulfated units of D-glucuronic acid and N-acetylglucosamine	Drug: Hyaluronic acid; Alveolar ridge preservation by atraumatic tooth extraction and socket curettage then application hyaluronic acid gel after extraction and covering the socket by collagen membrane.
Other: empty socket; extraction socket without application any drug	Other: empty socket; Alveolar ridge preservation by atraumatic tooth socket without application any drug but just covering the socket by collagen membrane.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical outcome	measurement clinical bone width of the socket by millimeter before and 4 months after extraction ...	baseline(before extraction)/ four months later after extraction
Radiographic measurement	Radiographic measurement of bone width by CBCt before and 4 months after extraction	baseline(before extraction)/ four months later after extraction
Radiographic measurement	Radiographic measurement of bone height by CBCt before and 4 months after extraction.	baseline (before extraction)/ four months later after extraction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
histological analysis	The bone biopsy will be taken by trephine bur. And evaluate bone quality.	after 4 months of extraction at the time of implant placement.
histomorphometric analysis	The bone biopsy will be taken by trephine bur. And evaluate bone quantity.	after 4 months of extraction at the time of implant placement.

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Suzan M Ibrahim, professor, Faculty of Dentistry-Ain shams university

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2021
• Primary Completion (Actual): February 26, 2022
• Study Completion (Actual): August 20, 2022

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: December 17, 2023
• First Posted (Estimated): December 20, 2023

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 17, 2023
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: hopeless anterior tooth; atraumatic extraction; hyaluronic acid gel
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: FD-ASU-REC.852

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No