Chlorhexidine Gel Versus Alvogyl Following Surgical Extraction of Impacted Mandibular Third Molar

NCT06144983 | Completed Phase 4 DMC

• 1 other identifier: 417121
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Background: One of the most frequent surgical operations in dentistry is the surgical extraction of the impacted mandibular third molar, which is accompanied by a sequelae of swelling, trismus, and pain. Various techniques have been employed to either prevent or reduce these postoperative outcomes. To the best of our knowledge, few clinical researchers have investigated the effect of local application of Alvogyl paste and Chlorhexidine gel, in the management of pain, facial swelling, and trismus resulting from lower third molar surgical extraction. Aim of the study: The study was meant to compare the effects of 0.2% chlorhexidine gel and Alvogyl paste on the reduction of the inflammatory reaction caused by the surgical extraction of the impacted mandibular third molar, which includes pain, facial swelling, and trismus.

Conditions

Impacted Third Molar Tooth

Keywords

chlorhexidine gel; Impacted Third Molar Tooth; alvogyl paste

Outcome Measures

Primary Outcomes (3)

• postoperative trismus

  A traditional Vernia caliper is used to measure the distance between the incisal edges of the upper and lower central incisors

  preoperativly and in the second and seventh postoperative day

• postoperative swelling

  Facial edema was assessed by measuring the distances between three selected lines, utilizing measuring tape, including the tragus of the ear to the outer corner of the mouth, the tragus to the soft tissue pogonion, and the distance that exists between the outer canthus of the eye and the angle of the mandible.

  preoperativly and in the second and seventh postoperative day

• postoperative pain

  The intensity of pain was assessed using the numeric rating scale (NRS), on which extreme scores start from zero (no pain) to 10 (worst pain possible). The recording of the pain was on two occasions, one at 10 o'clock am and the other at 10 o'clock pm at the same time except for the operation day in which the first recording was 4 hours after surgery and the second was at 10 o'clock pm, the mean of two records represented the pain for that day. The pain was recorded from the day of the operation until the seventh day. The scale was explained to every patient clearly as (0) represents the absence of pain, (1-2) simple pain, (3-4) low pain, (5-6) moderate tolerable pain, (7-8) intolerable severe pain that can be relieved by medication, and (9-10) intolerable severe pain not relieved by medication.

  throughout the first postoperative week

Study Arms (3)

Alvogyl paste

EXPERIMENTAL

Application of 0.2 gm of Alvogyl paste inside the extraction socket filling it entirely, and suturing the flap interrupted suture following impacted mandibular third molar surgery.

Drug: Alvogyl

Cholrhexidine gel

EXPERIMENTAL

Application of 1 ml of Chlorhexidine gel inside the extraction socket filling it entirely, and suturing the flap interrupted suture following impacted mandibular third molar surgery.

Drug: Chlorhexidine Gluconate

control

NO INTERVENTION

no dressing material was applied following the impacted mandibular third molar surgery.

Interventions

Alvogyl DRUG

In the first study group, (0.2gm) of Alvogyl paste (Septodont Inc., France), was inserted inside the alveolus, filling it entirely

Also known as: Alvogyl paste

Alvogyl paste

Chlorhexidine Gluconate DRUG

in the second group (1ml) of Periokin (Kin Inc., Spain), containing 0.2% Chlorhexidine bioadhesive gel was injected to fill the entire socket

Also known as: 0.2% Chlorhexidine gel

Cholrhexidine gel

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Absence of any history of systemic diseases that can impede wound healing or surgical operation.
• No history of recently using anti-inflammatory drugs.
• Patients aged ≥18 years who were indicated for surgical extraction of mesioangular, class I or II, and position A or B impacted mandibular third molar.
• Well-educated patients who had no objection to take part in the study and likely to comply with all study procedures.

You may not qualify if:

• Medical conditions that forbid surgical involvement, such as those in patients with bleeding-related conditions, recent myocardial infarctions, psychological issues, uncontrolled systemic diseases, immune-compromised patients, and patients who were on corticosteroid anti-inflammatory drugs.
• Recent history of head and neck radiotherapy.
• Pregnancy, and female patients taking contraceptives.
• Patients with severe localized infections in relation to the third molar, such as Pericoronitis, or those with severe periodontal disease and/or poor oral hygiene.
• Patients who were unable to come back for follow-up and recall appointments.
• Impacted third molar that interferes with the inferior alveolar nerve.
• Periapical pathology or cystic lesions related to the impacted tooth.
• Heavy smokers (more than 20 cigarettes/day).

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

University of Baghdad

Baghdad, 10064, Iraq

Location

Related Publications (1)

• Jesudasan JS, Wahab PU, Sekhar MR. Effectiveness of 0.2% chlorhexidine gel and a eugenol-based paste on postoperative alveolar osteitis in patients having third molars extracted: a randomised controlled clinical trial. Br J Oral Maxillofac Surg. 2015 Nov;53(9):826-30. doi: 10.1016/j.bjoms.2015.06.022. Epub 2015 Jul 16.

  PMID: 26188932 BACKGROUND

MeSH Terms

Interventions

butyl aminobenzoate, eugenol, iodoform, spearmint oil drug combinations; chlorhexidine gluconate

Study Officials

• Sahar sh Aladili, B.D.S.MS.C

  University of Baghdad

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: B.D.S

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 22, 2023
• Study Start: February 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)