Clinical trial

Chlorhexidine Gel Versus Alvogyl Following Surgical Extraction of Impacted Mandibular Third Molar (Comparative Study)

Name
417121
Description
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.
Trial arms
Trial start
2022-02-01
Estimated PCD
2022-09-01
Trial end
2022-09-01
Status
Completed
Phase
Early phase I
Treatment
Alvogyl
In the first study group, (0.2gm) of Alvogyl paste (Septodont Inc., France), was inserted inside the alveolus, filling it entirely
Arms:
Alvogyl paste
Other names:
Alvogyl paste
Chlorhexidine Gluconate
in the second group (1ml) of Periokin (Kin Inc., Spain), containing 0.2% Chlorhexidine bioadhesive gel was injected to fill the entire socket
Arms:
Cholrhexidine gel
Other names:
0.2% Chlorhexidine gel
Size
51
Primary endpoint
postoperative trismus
preoperativly and in the second and seventh postoperative day
postoperative swelling
preoperativly and in the second and seventh postoperative day
postoperative pain
throughout the first postoperative week
Eligibility criteria
Inclusion Criteria: 1. Absence of any history of systemic diseases that can impede wound healing or surgical operation. 2. No history of recently using anti-inflammatory drugs. 3. 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. 4. Well-educated patients who had no objection to take part in the study and likely to comply with all study procedures. Exclusion Criteria: 1. 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. 2. Recent history of head and neck radiotherapy. 3. Pregnancy, and female patients taking contraceptives. 4. 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. 5. Patients who were unable to come back for follow-up and recall appointments. 6. Impacted third molar that interferes with the inferior alveolar nerve. 7. Periapical pathology or cystic lesions related to the impacted tooth. 8. Heavy smokers (more than 20 cigarettes/day).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 51, 'type': 'ACTUAL'}}
Updated at
2023-11-22

1 organization

2 products

1 indication

Product
Alvogyl