Clinical trial NCT06144983: Chlorhexidine Gel Versus Alvogyl Following Surgical Extraction of Impacted Mandibular Third Molar
Official title: Chlorhexidine Gel Versus Alvogyl Following Surgical Extraction of Impacted Mandibular Third Molar (Comparative Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impacted Third Molar Tooth
Keywords: chlorhexidine gel
Impacted Third Molar Tooth
alvogyl paste
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

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.

Materials and Methods: This randomized control study was conducted from February 2022 to September 2022 on (51) patients, (23) male and (28) female, aged (18-39) years, who presented with impacted mandibular third molar. The participants were randomly allocated into three groups, 17 patients received Alvogyl paste (G1), 17 patients received 0.2% Chlorhexidine gel (Periokin) (G2), and 17 patients received nothing upon surgery (G3). The mouth opening and facial measurements were assessed preoperatively as a baseline reference and on the 2nd and 7th postoperative days. pain was assessed daily using a numerical rating scale (NRS) from the first day to the seventh day following surgery.

Results: Regarding the mouth opening, there was no statistically significant difference among the three groups in the degree of trismus on the second and seventh postoperative days (P ≥ 0.05).

In regards to postoperative facial edema and pain, there was a statistically significant difference among all groups (P \< 0.05), however, there was no statistically significant difference between the two study groups.

Conclusion: This study showed that Alvogyl paste and 0.2% Chlorhexidine bioadhesive gel significantly reduce postoperative pain and facial swelling with no significant effect on trismus following impacted mandibular third molar surgical extraction.

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).

Primary outcomes:
measure: postoperative trismus
timeFrame: preoperativly and in the second and seventh postoperative day
measure: postoperative swelling
timeFrame: preoperativly and in the second and seventh postoperative day
measure: postoperative pain
timeFrame: throughout the first postoperative week
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: University of Baghdad
Study officials:
affiliation: University of Baghdad
name: Sahar sh Aladili, B.D.S.MS.C
role: STUDY_DIRECTOR
References:
citation: 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.