Hyaluronic Acid Gel in Ridge Preservation

NCT06176937 | Completed Phase 4 DMC

• 1 other identifier: FD-ASU-REC.852
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyaluronic Acid Gel for Preservation the Extraction Socket

Keywords

hopeless anterior tooth; atraumatic extraction; hyaluronic acid gel

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• histological analysis

  after 4 months of extraction at the time of implant placement.

• histomorphometric analysis

  after 4 months of extraction at the time of implant placement.

Study Arms (2)

hyaluronic acid gel

ACTIVE COMPARATOR

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

empty socket

OTHER

extraction socket without application any drug

Other: empty socket

Interventions

Hyaluronic acid DRUG

Alveolar ridge preservation by atraumatic tooth extraction and socket curettage then application hyaluronic acid gel after extraction and covering the socket by collagen membrane.

hyaluronic acid gel

empty socket OTHER

Alveolar ridge preservation by atraumatic tooth socket without application any drug but just covering the socket by collagen membrane.

empty socket

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult patients as evidenced by Burkett's oral medicine health history questionnaire
• Both genders.
• Age from 20 -50 years old.
• Having at least one hopeless teeth indicated for extraction.
• Esthetic zone teeth (anterior or premolar).
• Sockets type 1 or 2 .
• Patient should agree to sign a written consent after the nature of the study will be explained.

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams University

Cairo, Egypt

Location

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Suzan M Ibrahim, professor

  Faculty of dentistry-Ain shams university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: December 20, 2023
• Study Start: October 13, 2021
• Primary Completion: February 26, 2022
• Study Completion: August 20, 2022
• Last Updated: December 20, 2023

Record last verified: 2020-01

Locations

EG (1)