NCT06456060

Brief Summary

Dry socket, or Alveolar Osteitis, is the most common complication that can follow a tooth extraction. Over the years, various approaches have been employed to expedite the healing process and alleviate the associated symptoms. Among these, Alvogyl has been the most commonly used dry socket dressing all over the globe. However due to Alvogyl's potential side effect of causing a foreign body reaction \& ultimately necrosis of the alveolar bone if left in the socket along with its high cost, scientists have sought to develop new techniques. Among them, Honey dressing has heralded promising properties in facilitating the resolution of dry socket, thus opening the window of a side-effect free natural viable alternative to Alvogyl. In this research, we aim to compare the efficacy of pure Honey as a dry socket dressing in comparison to Alvogyl.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2024

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

June 6, 2024

Last Update Submit

July 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain relief

    The patients will be requested to note daily pain records on a (0-10) visual analog scale, with 0 representing no pain and 10 representing the worst pain..

    Patients will be reviewed at 5 min post-medication, 30 min post-medication, 60 min post-medication, 2nd day post-medication, 4th day post-medication and 7th day post-medication.

Study Arms (2)

Control (Alvogyl) Group

ACTIVE COMPARATOR

In Control Group, after flushing the socket with normal saline a gauze soaked with Alvogyl will be used to cover the socket..

Drug: Alvogyl

Study (Honey) Group

EXPERIMENTAL

In the Study (Honey) Group, after flushing the socket with normal saline, 2 ml of Honey soaked in a sterile gauze will be applied to cover the socket.

Drug: Honey

Interventions

Alvogyl soaked in a sterile gauze will be applied to cover the socket.

Control (Alvogyl) Group
HoneyDRUG

Honey soaked in a sterile gauze will be applied to cover the socket.

Study (Honey) Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 18 years of age of both genders.
  • Patients who underwent extraction of teeth and were clinically diagnosed with dry socket at the OMFS department of NID, Multan.
  • Patients which give informed consent.

You may not qualify if:

  • Patients below the age of 18 and above the age of 70.
  • Patients with various bone diseases, including osteoporosis \& a history of taking oral or intravenous bisphosphonates
  • Patients with a history of radiotherapy on the head, neck, and jawbones were excluded from this study,
  • Patients with systemic diseases such as diabetes mellitus, hepatic dysfunctions, blood dyscrasias, and bleeding disorders
  • Patients with allergy to Ibuprofen \& honey
  • Patients having symptoms similar to dry socket due to retained root pieces, oroantral communication, or any bony or soft tissue pathology by the help of a radiograph
  • Patients who did not give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nishtar Institute of Dentistry

Multan Khurd, Punjab Province, Pakistan

RECRUITING

Related Publications (3)

  • Keshini MP, Shetty SK, Sundar S, Chandan SN, Manjula S. Assessment of Healing Using Alvogyl and Platelet Rich Fibrin in Patients with Dry Socket - An Evaluative Study. Ann Maxillofac Surg. 2020 Jul-Dec;10(2):320-324. doi: 10.4103/ams.ams_259_19. Epub 2020 Dec 23.

  • Abu-Mostafa N, Al-Daghamin S, Al-Anazi A, Al-Jumaah N, Alnesafi A. The influence of intra-alveolar application of honey versus Chlorhexidine rinse on the incidence of Alveolar Osteitis following molar teeth extraction. A randomized clinical parallel trial. J Clin Exp Dent. 2019 Oct 1;11(10):e871-e876. doi: 10.4317/jced.55743. eCollection 2019 Oct.

  • Soni N, Singh V, Mohammad S, Singh RK, Pal US, Singh R, Aggrwal J, Pal M. Effects of honey in the management of alveolar osteitis: A study. Natl J Maxillofac Surg. 2016 Jul-Dec;7(2):136-147. doi: 10.4103/0975-5950.201354.

MeSH Terms

Conditions

Dry Socket

Interventions

butyl aminobenzoate, eugenol, iodoform, spearmint oil drug combinationsHoney

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Muhammad Ilyas, MBBS, FCPS

    Watim Medical & Dental College

    STUDY DIRECTOR

Central Study Contacts

Muhammad Raif Ilyas, BDS, FCPS -1

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be blinded about the use of honey or Alveogyl in the dressing.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be divided into the following two groups: 1. Study group 2. Control group In the study group, after flushing the socket with normal saline, 2 ml of Honey soaked in a sterile gauze will be applied to cover the socket, whereas in the control group, a gauze with Alveogyl will be used to cover the socket instead of Honey.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 6, 2024

First Posted

June 13, 2024

Study Start

June 1, 2024

Primary Completion

December 30, 2024

Study Completion

January 30, 2025

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations