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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04779476
Other study ID # FRP/2021/319
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 4, 2021
Est. completion date December 2021

Study information

Verified date October 2021
Source Riyadh Elm University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to assess the post-dental extraction pain following the application of two different dressing materials. Alvogyl® and Absorbable gelatin sponges


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers
Gender All
Age group 13 Years to 22 Years
Eligibility Inclusion Criteria: - Single tooth extraction - Upper and lower teeth Exclusion Criteria: - Surgical extraction - Medically compromised patients - Presence of active infection - Presence of pathology

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Socket Dressing
Following dental extraction immediately, the socket will be dressed with one of the materials tested

Locations

Country Name City State
Saudi Arabia Ahmad Assari Riyadh

Sponsors (1)

Lead Sponsor Collaborator
Riyadh Elm University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (4)

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. — View Citation

Kafali H, Iltemur Duvan C, Gözdemir E, Simavli S, Oztürk 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: 10.10 — View Citation

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. — View Citation

Summers L, Matz LR. Extraction wound sockets. Histological changes and paste packs--a trial. Br Dent J. 1976 Dec 21;141(12):377-9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 3 hrs post extraction pain Visual analogue scale score for pain three hours after the extraction
Primary 6 hrs post extraction pain Visual analogue scale score for pain six hours after the extraction
Primary 12 hrs post extraction pain Visual analogue scale score for pain twelve hours after the extraction
Primary 24 hrs post extraction pain Visual analogue scale score for pain twenty-four hours after the extraction
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