Facial PainNCT04779476
Effectiveness of Alveogyl and Cutanplast Dressing on Postoperative Pain Following Tooth Extraction: A Clinical Trial
An observational study of Facial Pain and Pain, Postoperative, run by Riyadh Elm University at 1 site in Saudi Arabia.
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 Read more about this study
- Who is it for?
- Ages 13 to 22 years
- Conditions the study is for
- Facial Pain, Pain, Postoperative, Pain, Orofacial
- What is being tested?
- Socket Dressing
- How many people
- 50 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 4 Mar 2021to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 22 years
- All sexes
- Child, Adult
Study population: Patients referred from the orthodontic department for extraction of p
Who may be able to join
- Single tooth extraction
- Upper and lower teeth
Who cannot join
- Surgical extraction
- Medically compromised patients
- Presence of active infection
- Presence of pathology
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to assess the post-dental extraction pain following the application of two different dressing materials.
Alvogyl® and Absorbable gelatin sponges
Read the 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.
- Conditions
- Facial Pain, Pain, Postoperative, Pain, Orofacial
- Being tested
- Socket Dressing
- Keywords
- Alveogyl, Eugenol, Dental extraction, Post extraction pain
- Medical subject headings
- Facial Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket DressingOther
Following dental extraction immediately, the socket will be dressed with one of the materials tested
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No dressing material will be used post dental extraction | |
| Alveogyl Group | Alveogyl will be placed in the dental socket after extraction Receives: Other: Socket Dressing | |
| Cutanplast Group | Absorbable gelatin sponges contain will be placed in the dental socket after extraction Receives: Other: Socket Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 hrs post extraction pain
Visual analogue scale score for pain
Measured: three hours after the extraction
6 hrs post extraction pain
Visual analogue scale score for pain
Measured: six hours after the extraction
12 hrs post extraction pain
Visual analogue scale score for pain
Measured: twelve hours after the extraction
24 hrs post extraction pain
Visual analogue scale score for pain
Measured: twenty-four hours after the extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start4 Mar 2021
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Facial PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riyadh Elm University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Assari, Riyadh Elm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779476
- Sponsor's protocol ID
- FRP/2021/319
- Status last verified
- Oct 2021
- First submitted
- 27 Feb 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The anticipated number may not be reached
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.
PubMed 10982947Summers 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.
PubMed 1070322Kaur 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.
PubMed 20043298Kafali 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.
PubMed 18971135
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Alveogyl and Cutanplast Dressing on Postoperative Pain Following Tooth Extraction: A Clinical Trial
- ClinicalTrials.gov ID
- NCT04779476
- Acronym / sponsor ID
- FRP/2021/319
- Conditions
- Facial Pain, Pain, Postoperative, Pain, Orofacial
- Keywords
- Alveogyl, Eugenol, Dental extraction, Post extraction pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Riyadh Elm UniversityUniversity, hospital or other
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the post-dental extraction pain following the application of two different dressing materials.
Alvogyl® and Absorbable gelatin sponges
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –No dressing material will be used post dental extraction |
| Alveogyl Group | – | Other: Socket DressingAlveogyl will be placed in the dental socket after extraction |
| Cutanplast Group | – | Other: Socket DressingAbsorbable gelatin sponges contain will be placed in the dental socket after extraction |
Who may qualify
- Ages
- 13 to 22 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients referred from the orthodontic department for extraction of p
Key inclusion criteria (2 listed)
- Single tooth extraction
- Upper and lower teeth
Key exclusion criteria (4 listed)
- Surgical extraction
- Medically compromised patients
- Presence of active infection
- Presence of pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Socket DressingFollowing dental extraction immediately, the socket will be dressed with one of the materials tested | Other | Alveogyl Group, Cutanplast Group |
Primary outcome
3 hrs post extraction pain
Time frame: three hours after the extraction
Visual analogue scale score for pain
6 hrs post extraction pain
Time frame: six hours after the extraction
Visual analogue scale score for pain
12 hrs post extraction pain
Time frame: twelve hours after the extraction
Visual analogue scale score for pain
24 hrs post extraction pain
Time frame: twenty-four hours after the extraction
Visual analogue scale score for pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Results publication: PubMed 10982947Bloomer 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.
- Results publication: PubMed 1070322Summers 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.
- Results publication: PubMed 20043298Kaur 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.
- Results publication: PubMed 18971135Kafali 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.
- Individual participant dataSharing planned: Undecided. The anticipated number may not be reached
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Facial Pain and Pain, Postoperative, run by Riyadh Elm University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 hrs post extraction pain (time frame: three hours after the extraction). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04779476, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.