Hyaluronic Acid and Amino Acid Gel Applied to the Alveolar Socket After Mandibular Third Molar Extraction

NCT03428698 | Completed

• 1 other identifier: 1987/P
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: The study aimed to assess the effect of topical application of an amino acid + sodium hyaluronate acid gel after lower third molar extraction. Study design: 136 patients requiring lower third molar extraction were enrolled. An amino acid + sodium hyaluronate acid (HA) gel was applied to the sockets of the patients in the treatment group immediately following extraction; the sockets of the controls were simply flushed with a sterile saline solution. 7 and 14 days after surgery, patients' outcomes and postoperative complications were evaluated. Cumulative incidence of dehiscence and secondary outcome measures were analyzed using a chi-square test.

Conditions

Pain; Oral Surgery; Third Molar Extraction

Keywords

third molar extraction; hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• cumulative incidence of dehiscence

  Surgical wound dehiscence is defined as a pathologic process consisting of a partial or complete disruption of the buccal and lingual mucosa layers of a surgical wound.

  14 days

Study Arms (2)

experimental device

EXPERIMENTAL

The extraction was completed, the socket was filled with a topical amino acid + sodium hyaluronate gel (Aminogam®, sterile syringe 2 ml).

Device: Aminogam

control no device

PLACEBO COMPARATOR

The extraction was completed, socket was flushed, using a 2ml sterile syringe similar to one utilized to apply the gel, with sterile physiological solution.

Device: Aminogam

Interventions

Aminogam DEVICE

A lower third molar was extracted. All the surgical tools and materials as well as the surgical field were sterile. A full-thickness flap was raised and, if necessary, osteotomy and tooth sectioning were performed using a straight handpiece with dedicated burs under copious irrigation with sterile saline solution. The extraction was completed with curved and straight extractors, the socket was closely inspected and the dental follicle was removed. Depending on the group to which the patient was assigned, one of the following procedures was carried out.

control no device; experimental device

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age 18 between 25 years,
• ASA I or II,
• necessitating lower wisdom tooth extraction,
• no evidence of inflammation

You may not qualify if:

• smoking more than 10 cigarettes a day,
• pregnancy,
• uncontrolled diabetes mellitus,
• any diseases contraindicating the surgical procedure,
• use of bisphosphonate,
• antibiotics or NSAIDs during the 30 days preceding surgery

Sponsors & Collaborators

• University of Padova, School of Dental Medicine: lead

Study Sites (1)

University of Padova

Padua, 35100, Italy

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefano Sivolella, DDS, PhD

  University of Padova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, PhD, MSc

Study Record Dates

• First Submitted: February 4, 2018
• First Posted: February 12, 2018
• Study Start: September 10, 2009
• Primary Completion: September 10, 2010
• Study Completion: November 25, 2011
• Last Updated: February 12, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)