Effectiveness of Alveogyl and Cutanplast Dressing on Postoperative Pain Following Tooth Extraction: A Clinical Trial

This study aims to assess the post-dental extraction pain following the application of two different dressing materials.

Alvogyl® and Absorbable gelatin sponges

Study Overview

• Status: Active, not recruiting
• Conditions: Pain, Postoperative; Facial Pain; Pain, Orofacial
• Intervention / Treatment: Other: Socket Dressing

Detailed Description

Effective postoperative pain relief improves the quality of recovery and the resumption of normal activities. Many options are available for postoperative pain relief following tooth extraction including systemic analgesic, intra-alveolar socket dressing medicaments, and follow the postoperative instructions; the choice of the medication determined by drug availability, chance of side effect of some drugs and financial considerations. The use of intra-alveolar dressing materials is widely suggested in the literature such as Alvogyl® that used as palliative treatment which includes eugenol (analgesic, anti-inflammatory), iodoform (antimicrobial), and butamen (anesthetic). Absorbable gelatin sponges contain haemostatic material and may be used for local application in surgical procedures where traditional haemostasis is difficult. In addition to its haemostatic effect, an absorbable gelatin sponge can be used as a drug reservoir to provide sustained release of drugs

The aim of this study is to measure the pain intensity after using socket dressing materials following tooth extraction.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • Ahmad Assari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 22 years (ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients referred from the orthodontic department for extraction of p

Description

Inclusion Criteria:

• Single tooth extraction
• Upper and lower teeth

Exclusion Criteria:

• Surgical extraction
• Medically compromised patients
• Presence of active infection
• Presence of pathology

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control Group; No dressing material will be used post dental extraction
Alveogyl Group; Alveogyl will be placed in the dental socket after extraction	Other: Socket Dressing; Following dental extraction immediately, the socket will be dressed with one of the materials tested
Cutanplast Group; Absorbable gelatin sponges contain will be placed in the dental socket after extraction	Other: Socket Dressing; Following dental extraction immediately, the socket will be dressed with one of the materials tested

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3 hrs post extraction pain	Visual analogue scale score for pain	three hours after the extraction
6 hrs post extraction pain	Visual analogue scale score for pain	six hours after the extraction
12 hrs post extraction pain	Visual analogue scale score for pain	twelve hours after the extraction
24 hrs post extraction pain	Visual analogue scale score for pain	twenty-four hours after the extraction

Collaborators and Investigators

• Sponsor: Riyadh Elm University

Publications and helpful links

General Publications

• Bloomer CR. Alveolar osteitis prevention by immediate placement of medicated packing. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000 Sep;90(3):282-4. doi: 10.1067/moe.2000.108919.
• Summers L, Matz LR. Extraction wound sockets. Histological changes and paste packs--a trial. Br Dent J. 1976 Dec 21;141(12):377-9. doi: 10.1038/sj.bdj.4803851. No abstract available.
• Kaur G, Athar M, Alam MS. Eugenol precludes cutaneous chemical carcinogenesis in mouse by preventing oxidative stress and inflammation and by inducing apoptosis. Mol Carcinog. 2010 Mar;49(3):290-301. doi: 10.1002/mc.20601.
• Kafali H, Iltemur Duvan C, Gozdemir E, Simavli S, Ozturk Turhan N. Placement of bupivacaine-soaked Spongostan in episiotomy bed is effective treatment modality for episiotomy-associated pain. J Minim Invasive Gynecol. 2008 Nov-Dec;15(6):719-22. doi: 10.1016/j.jmig.2008.08.006.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 4, 2021
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: February 27, 2021
• First Submitted That Met QC Criteria: February 27, 2021
• First Posted (ACTUAL): March 3, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Alveogyl; Dental extraction; Eugenol; Post extraction pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Facial Pain
• Other Study ID Numbers: FRP/2021/319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The anticipated number may not be reached

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No