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

NCT ID: NCT03428698

Last Updated: 2018-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-10
• Study Completion Date: 2011-11-25

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.

Detailed Description

A lower third molar was extracted under local anesthesia generally involving an inferior alveolar nerve block associated with a buccal nerve block (2% mepivacaine with 1:100,000 epinephrine, Optocain, Molteni Dental, Italy), plus sedation as necessary. 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. The bone edges were refined to remove the bone spurs with a bone lime and then irrigated with abundant sterile 0.9% saline solution. Depending on the group to which the patient was assigned, one of the following procedures was carried out: the socket was filled with a topical amino acid + sodium hyaluronate gel (Aminogam®, sterile syringe 2 ml) or the socket was flushed, using a 2ml sterile syringe similar to one utilized to apply the gel, with sterile physiological solution. The flap was then repositioned and sutured (Novosyn 4.0, B. Braun AG, Melsungen, Germany) to allow healing by primary intention. After surgery, the patients were prescribed antibiotics (amoxicillin clavulanate 1 g every 12 hours for 6 days, or clarithromycin 250 mg every 12 hours for 6 days) and painkillers (paracetamol 1000 mg every 8 hours was recommended). The patients were also provided standard postoperative recommendations regarding activity, diet, and smoking. The following data were registered at the time of surgery: the range of pre-operative mouth opening measurement (assessed by measuring the distance between the incisors), the type of sedation utilized, if osteotomy or root resection was carried out, the quantity of peri-operative bleeding, the amount of time between incision and suture (surgical procedure time).

Conditions

Pain; Oral Surgery; Third Molar Extraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

experimental device

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

Group Type: EXPERIMENTAL

Aminogam

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Aminogam

Intervention Type: 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.

Interventions

Aminogam

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Padova, School of Dental Medicine

OTHER

Sponsor Role: lead

Responsible Party

Stefano Sivolella

DDS, PhD, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefano Sivolella, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Padova

Locations

University of Padova

Padua, , Italy

Countries

Italy

Other Identifiers

1987/P

Identifier Type: -

Identifier Source: org_study_id