A Phase 4 interventional study of Iodoform and Wound closure using sutures in Alveolitis of Jaw, Alveoli, Teeth; Inflammation and Dry Socket, sponsored by University of Pecs. Status unknown at 1 site in Hungary. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-15.
Sponsored by University of Pecs · Phase 4, Interventional, and Prevention
In the everyday clinical practice the incidence of minor complications is approximately 15-20% of the total number of third molar removals. Alveolitis (dry socket syndrome) may arise in 30-40% of the surgical tooth removals. Several preventive approaches are known, such as the use of iodoform gauze, zink-oxide eugenol paste, platelet rich fibrin (PRF), different medicine containing pastes, like antibiotics containing, non-steroid pain killer containing, steroid containing, or the application of chlorhexidine gel and solutions. In the case of a manifest alveolitis these methods can be used as well. The aims of this research are: i) to identify the important pathogens which play role in the development of alveolitis (microbiological methods), ii) to analyze the in vitro effectivity of the different antiseptic materials in case of infections (inhibitory zones) iii) to compare the effectivity of different alveolitis preventive methods in a prospective clinical study, iv) to compare the different treatment options in alveolitis in a prospective clinical study.
46 studies on the registry are indexed under Dry Socket; 10 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 41 interventional studies indexed under Dry Socket.
Browse Dry Socket studies →University of Pecs is the lead sponsor of 106 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Routine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only.
Other: Wound closure using sutures
Patients get iodoform (1000 grams containing 350 grams of iodoform, 300 grams of glycerin and 350 grams of alcohol 96%) soaked gauze (steril selvedge gauze bandage 2 cm x 5 m in appropriate length) drainage during suture (Surgilon 3-0 non-absorbable) placements for a week.
Drug: Iodoform · Other: Wound closure using sutures
Extraction sockets are filled with 1% chlorhexidine gel (Curasept ADS310, Sager Pharma, Sager Dental Kft.,Budapest, Hungary) before suture (Surgilon 3-0 non-absorbable) placements.
Other: Wound closure using sutures · Drug: Chlorhexidine
Patients get iodoform (1000 grams containing 350 grams of iodoform, 300 grams of glycerin and 350 grams of alcohol 96%) soaked gauze (steril selvedge gauze bandage 2 cm x 5 m in appropriate length) drainage during suture placements for a week.
Routine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only.
Extraction sockets are filled with 1% chlorhexidine gel (Curasept ADS310, Sager Pharma, Sager Dental Kft.,Budapest, Hungary) before suture (Surgilon 3-0 non-absorbable) placements.
Change in minor postoperative complications (trismus)
Measuring postoperative trismus (maximal mouth opening - inter-incisal distance in millimeters).
Time frame: day of surgery, 3rd, 7th postoperative days
Change in minor postoperative complications (oedema)
measuring postoperative oedema (flexible ruler- lateral canthus-mandibular angle distance in millimeters and tragus-labial commissure distance in millimeters).
Time frame: day of surgery, 3rd, 7th postoperative days
Change in minor postoperative complications (pain)
Measuring level of pain in Visual Analog Scale (minimum score is 0 which represents no pain, maximum score is 10 which shows the worst pain) postoperatively
Time frame: 1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days
Change in necessity of postoperatively taken analgesics
Registering dose of active agent of taken analgesics in milligrams .
Time frame: 1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days
Change in necessity of postoperatively taken analgesics
Registering number of daily repeats of taken analgesics.
Time frame: 1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days
Plan to share: Undecided
No publications or documents are linked to this record.
Started Sep 2018 (actual). Primary completion is estimated for Sep 2020, 24 months after the start.
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This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Iodoform · Chlorhexidine