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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Alveolar Osteitis
• Intervention / Treatment: Drug: Alvogyl; Drug: Eugenol; Drug: Nigella Sativa Oil

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: MUHAMMAD BILAL; Phone Number: +92519315698; Email: Bilalkhan321@gmail.com

Study Locations

• Pakistan
  • Panjab
    • Taxila Cantt, Panjab, Pakistan, 47070
      • Department of Oral & Maxillofacial Surgery-Dental College HITEC-IMS TAXILA CANTT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alvogyl; this group will be assigned Alvogyl as treatment drug	Drug: Alvogyl; this is standard treatment drug
Experimental: Eugenol; this group will be assigned Eugenol as treatment drug	Drug: Eugenol; this not standard drug for the treatment of Alveolar Osteitis but an antiseptic agent
Experimental: Black Seed Oil; this group will be assigned Nigella Sativa as treatment drug	Drug: Nigella Sativa Oil; it not standard medicine for Alveolar Osteitis. it is a herbal medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale	pain will assessed using Visual Analogue scale on day 2, 6, 10 and 14th after the start of treatment. Visual Analogue Score measurement will be scale based from 1 to 10 score. Where 1-3 is mild, 3-7 is moderate and 7-10 will be scored as severe pain.	14 days
Periodontal Probe	alveolar osteitis affected extraction socket will be observed for the resolution of inflammation and healing will be assessed on day 2, 6, 10 and 14 by clinical examination with periodontal Probe. Periodontal depth will be measured in mm, by using the periodontal probe where the depth of 1 to 3 mm is considered well healed socket, 4-6 mm indicates moderately inflamed, 7 mm and above is considered severely inflammed .	14 days

Collaborators and Investigators

• Sponsor: HITEC-Institute of Medical Sciences
• Investigators: Study Director: MAIMOONA Siddiq Dr, BDS-FCPS, Department of Oral & Maxillofacial Surgery-Dental College HITEC-IMS; Principal Investigator: Muhammad Bilal Dr, BDS, Department of Oral & Maxillofacial Surgery-Dental College HITEC-IMS

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: January 19, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Alveolar Osteitis; Eugenol; Alvogyl; Black seed oil; Extraction socket
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Osteitis; Dry Socket; Anti-Infective Agents; Eugenol
• Other Study ID Numbers: Bilalkhan321@gmail.com

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: its not required for trial registry. if at any time during trial registration it is asked , i will provide the data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No