Clinical trial NCT06823544: A Comparative Single Blind Clinical Study on the Effect of Alvogyl, Eugenol, and Nigella Sativa (Black Seed Oil) for Alveolar Osteitis.
Official title: A Comparative Single Blind Clinical Study on the Effect of Alvogyl, Eugenol, and Nigella Sativa (Black Seed Oil) for Alveolar Osteitis.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Alveolar Osteitis
Keywords: Alveolar Osteitis
Alvogyl
Black seed oil
Eugenol
Extraction socket
Lead sponsor: HITEC-Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dry socket the unscientific term also known as alveolar or fibrinolytic osteitis is the most common postoperative complication following tooth extraction.

Treatment of Alveolar osteitis can be either pharmacological on non-pharmacological. Management can be by irrigation, surgical intervention and placement of medicated dressing such as topical anti-bacterial, topical anesthetics and obtundants or combination of these three.this study aims to find the best and effective treatment for dry socket comparing Alveogyl, Eugenol and Black seed oil at this institution.

Detailed description: Dry socket the unscientific term also known as alveolar or fibrinolytic osteitis is the most common postoperative complication following tooth extraction. Dry socket lesion occur in approximately 1% to 5% of all extraction and up to 38% of mandibular third molar extractions. The etiology of dry socket is not yet fully understood, however the disintegration of the blood clot at the site of the tooth extraction fails to develop i.e. fibrinolysis is widely accepted as the primary mechanism or it dislodges before wound has healed. Various factors have been associated with an increase of dry socket, although some of them remain controversial and many include difficult or traumatic extractions, oral hygiene, smoking, Gender (female), extraction site, previous dry socket history, while incidence can be reduced with the chlorhexidine rinse and gel of alveolar osteitis.

Treatment of Alveolar osteitis can be either pharmacological on non-pharmacological. Management can be by irrigation, surgical intervention and placement of medicated dressing such as topical anti-bacterial, topical anesthetics and obtundants or combination of these three. Out of these Alveogyl is the still the material of choice in terms of pain relief, wound healing and low incidence of dry socket as compared to honey, zinc oxide eugenol and cutanplast , however in some recent studies a mixture of Nigella sativa powder and oil showed that it is more efficacious dressing material for the management of dry socket compared to alvogyl, it provided immediate and complete pain relief and fewer number of repeated visits needed while in some neocane was the most suitable dressing material for the management of dry socket by virtue of shorter time required for the complete pain relief, fewer visits required and faster clinical healing. Based on the previous data, we decided to conduct a study to evaluate the effectiveness of nigella sativa (black seed oil) for the treatment of dry socket compared to alveogyl and eugenol both. To the best of our knowledge, this is the first comparative study of nigella sativa oil for the treatment of dry socket at Oral and maxillofacial surgery department, HITEC dental college, Taxila and is aimed to find the best and effective treatment for dry socket comparing Alveogyl, Eugenol and Black seed oil at this institution.

Eligibility criteria: Inclusion Criteria:

1. Patients over the age of 16, from both genders, who had their teeth extracted and were clinically diagnosed with dry socket.
2. Absence of systematic disease.

Exclusion Criteria:

1. SMOKER
2. ALCOHOLIC
3. Patients under the age of 16 years and over the age of 70 years
4. Patient with various bone diseases including osteoporosis.
5. Patients who had a history of taking oral or intravenous bisphosphonates.
6. Patients with a history of radiotherapy to the head and neck and jawbones.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 14 days
measure: Periodontal Probe
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taxila Cantt
country: Pakistan
facility: Department of Oral & Maxillofacial Surgery-Dental College HITEC-IMS TAXILA CANTT
state: Panjab
Study officials:
affiliation: Department of Oral & Maxillofacial Surgery-Dental College HITEC-IMS
name: MAIMOONA Siddiq Dr, BDS-FCPS
role: STUDY_DIRECTOR
affiliation: Department of Oral & Maxillofacial Surgery-Dental College HITEC-IMS
name: Muhammad Bilal Dr, BDS
role: PRINCIPAL_INVESTIGATOR
References: