NCT04779476

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

March 4, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

October 12, 2021

Status Verified

October 1, 2021

Enrollment Period

9 months

First QC Date

February 27, 2021

Last Update Submit

October 11, 2021

Conditions

Keywords

AlveogylEugenolDental extractionPost extraction pain

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (3)

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

Cutanplast Group

Absorbable gelatin sponges contain will be placed in the dental socket after extraction

Other: Socket Dressing

Interventions

Following dental extraction immediately, the socket will be dressed with one of the materials tested

Alveogyl GroupCutanplast Group

Eligibility Criteria

Age13 Years - 22 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Patients referred from the orthodontic department for extraction of p

You may qualify if:

  • Single tooth extraction
  • Upper and lower teeth

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmad Assari

Riyadh, Saudi Arabia

Location

Related 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. 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.

MeSH Terms

Conditions

Facial PainPain, Postoperative

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Ahmad Assari

Study Record Dates

First Submitted

February 27, 2021

First Posted

March 3, 2021

Study Start

March 4, 2021

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

October 12, 2021

Record last verified: 2021-10

Locations