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Not yet recruitingNCT06823544Updated Feb 12, 2025

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

A Phase 2 interventional study of Alvogyl and Eugenol in Alveolar Osteitis, sponsored by HITEC-Institute of Medical Sciences. Not yet recruiting at 1 site in Pakistan. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-02-12.

Sponsored by HITEC-Institute of Medical Sciences · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
16 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Alveolar Osteitis

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Keywords

  • Alveolar Osteitis
  • Alvogyl
  • Black seed oil
  • Eugenol
  • Extraction socket
03

In context

Dry Socket

46 studies on the registry are indexed under Dry Socket; 10 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 41 interventional studies indexed under Dry Socket.

Browse Dry Socket studies →

Lead sponsor

HITEC-Institute of Medical Sciences is the lead sponsor of 14 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Alvogyl

    this group will be assigned Alvogyl as treatment drug

    Drug: Alvogyl

  • Experimental
    Eugenol

    this group will be assigned Eugenol as treatment drug

    Drug: Eugenol

  • Experimental
    Black Seed Oil

    this group will be assigned Nigella Sativa as treatment drug

    Drug: Nigella Sativa Oil

Interventions

  • this is standard treatment drug

  • DrugEugenol

    this not standard drug for the treatment of Alveolar Osteitis but an antiseptic agent

  • it not standard medicine for Alveolar Osteitis. it is a herbal medicine

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 14 days

  2. 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 .

    Time frame: 14 days

07

Study locations

1 site
  • Department of Oral & Maxillofacial Surgery-Dental College HITEC-IMS TAXILA CANTT
    Taxila Cantt, Panjab 47070, Pakistan
08

References and documents

Individual participant data

Plan to share: No — its not required for trial registry. if at any time during trial registration it is asked , i will provide the data

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2025; primary completion for Jul 2025, 5 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 19, 2025
First posted
Feb 12, 2025
StartEst.
Feb 1, 2025
Primary completionEst.
Jul 31, 2025
CompletionEst.
Aug 31, 2025
Last update
Feb 12, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06823544
Lead sponsor
HITEC-Institute of Medical Sciences
Responsible party
Mohammad Bilal (Principal Investigator, HITEC-Institute of Medical Sciences) — Principal investigator
First posted
Feb 12, 2025
Start date
Feb 1, 2025 (estimated)
Primary completion
Jul 31, 2025 (estimated)
Completion
Aug 31, 2025 (estimated)
Last update
Feb 12, 2025

Study contacts

MUHAMMAD BILAL
Contact
Bilalkhan321@gmail.com
+92519315698
MAIMOONA Siddiq Dr, BDS-FCPS
study director · Department of Oral & Maxillofacial Surgery-Dental College HITEC-IMS
Muhammad Bilal Dr, BDS
principal investigator · Department of Oral & Maxillofacial Surgery-Dental College HITEC-IMS

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Butyl aminobenzoate, eugenol, iodoform, spearmint oil drug combinations · Nigella sativa oil

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