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Comparition of hemostatic effect, the amount of pain and the incidence of dry socket in a new gelatin sponge (dental geltamp) with commercial geltamp

A double-blind split-mouth clinical trial to compare hemostatic effect, the amount of pain, and the incidence of dry socket in a new gelatin sponge (dental geltamp) with commercial geltamp in patients who need mandibular first and second molar extraction

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200919048756N4
Enrollment
26
Registered
2022-05-02
Start date
2022-05-19
Completion date
Unknown
Last updated
2022-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extraction of the first and second mandibular teeth. Alveolitis of jaws

Interventions

Intervention 1: Test group: One of the two first or second mandibular of patients in which the production geltamp (a sponge made of gelatin without any drug) will be placed. How to use
In each patient, after extracting the tooth, a production geltamp will be placed in the extracted tooth cavity. Duration of use: It will remain in the place for at least 4 days (due to the patient's c
In each patient, after extracting the tooth, a commercial geltamp will be placed in the extracted tooth cavity. Duration of use: It will remain in the place for at least 4 days (due to the patient's c

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: Need for extraction of two mandibular first molars Age between 20-45 years No corticosteroids and antibiotics using in the last month No coagulation disorders No acute or uncontrolled infection at the dental surgery site No malignancy at the dental surgery site No site exposure Radiation surgery No contraceptives using at last month No smoking No hypertension, diabetes, thyroid disorders and blood diseases

Exclusion criteria

Exclusion criteria: People taking anticoagulants Not signing the consent form Having a systemic disease Patients whose teeth do not come out normally and need surgery and sectioning

Design outcomes

Primary

MeasureTime frame
Blood clotting. Timepoint: The amount of bleeding will be recorded after the anesthesia is gone (within 1-4 hours after tooth extraction) and the amount of uncontrollable bleeding after 4 hours will be considered as active bleeding. Method of measurement: In the study groups, sterile gas is changed every 15 minutes to completely stop the bleeding. The difference in weight of sterile gas at the beginning and after blood absorption will indicate the amount of blood absorption of each sterile gas. The number of sterile gases consumed and the total weight of sterile blood gases absorbed in each group (test and control) will be compared.;The amount of pain. Timepoint: The amount of pain will be measured in the first 12 hours after tooth extraction, as well as in the 24 hour period, 36 hours after tooth extraction. Method of measurement: And the patient will determine the amount of pain in four time periods from 1 (minimum pain) to 10 (maximum pain) by ticking.;The incidence of dry socket. Timepoint: All patients will be examined 4 days later and will be evaluated for the occurrence of dry socket. Method of measurement: All patients are referred for examination 4 days later and are evaluated for dry socket. Clinical examination of the patient and completion of information forms will be used to collect information.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Ali Ghavimi

Tabriz University of Medical Sciences

m_ghavimi@yahoo.com+98 41 3335 3161

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026