A Comparative Single Blind Clinical Study on the Effect of Alvogyl, Eugenol, and Nigella Sativa (Black Seed Oil) for Alveolar Osteitis.

HITEC-Institute of Medical Sciences

Status and phase: Not yet enrolling; Phase 2

Conditions: Alveolar Osteitis

Treatments: Drug: Eugenol; Drug: Nigella Sativa Oil; Drug: Alvogyl

Study type: Interventional

Funder types: Other

Identifiers

NCT06823544

[e-mail]

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 3 patient groups

Alvogyl

Experimental group

Description:

this group will be assigned Alvogyl as treatment drug

Treatment:

Drug: Alvogyl

Eugenol

Experimental group

Description:

this group will be assigned Eugenol as treatment drug

Treatment:

Drug: Eugenol

Black Seed Oil

Experimental group

Description:

this group will be assigned Nigella Sativa as treatment drug

Treatment:

Drug: Nigella Sativa Oil