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

• Sponsor: Riyadh Elm University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04779476
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 8.9
• Patients Per Site Per Month: 5.6

Study Details

Study Description

Brief Summary

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

Alvogyl® and Absorbable gelatin sponges

Condition or Disease	Intervention/Treatment	Phase
Facial Pain; Pain, Postoperative; Pain, Orofacial	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 Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effectiveness of Alveogyl and Cutanplast Dressing on Postoperative Pain Following Tooth Extraction: A Clinical Trial
• Actual Study Start Date: Mar 4, 2021
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 3 hrs post extraction pain [three hours after the extraction]

   Visual analogue scale score for pain

2. 6 hrs post extraction pain [six hours after the extraction]

   Visual analogue scale score for pain

3. 12 hrs post extraction pain [twelve hours after the extraction]

   Visual analogue scale score for pain

4. 24 hrs post extraction pain [twenty-four hours after the extraction]

   Visual analogue scale score for pain

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 22 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• Single tooth extraction

• Upper and lower teeth

Exclusion Criteria:

• Surgical extraction

• Medically compromised patients

• Presence of active infection

• Presence of pathology

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmad Assari	Riyadh		Saudi Arabia

Sponsors and Collaborators

• Riyadh Elm University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmad Assari, Dr. Ahmad Assari, Riyadh Elm University
• ClinicalTrials.gov Identifier: NCT04779476
• Other Study ID Numbers: FRP/2021/319
• First Posted: Mar 3, 2021
• Last Update Posted: Oct 12, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ahmad Assari, Dr. Ahmad Assari, Riyadh Elm University: Alveogyl; Eugenol; Dental extraction; Post extraction pain
• Additional relevant MeSH terms: Pain, Postoperative; Facial Pain

Study Results

No Results Posted as of Oct 12, 2021