A Phase 4 interventional study of Surgical crown lengthening and Augmentin in Tooth Diseases and Tooth Wear, sponsored by Biruni University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-19.
Sponsored by Biruni University · Phase 4, Interventional, and Treatment
The goal of this clinical trial is to test the effects of prophylactic antibiotics in healthy individuals who are in need of surgical crown lengthening. The main question it aims to answer is if single dose antibiotics prior to surgical crown lengthening has any effects on the healing outcomes.
Participants will be asked to take either
Researchers will compare the wound healing and self-reported outcomes of the antibiotics group and placebo group.
62 studies on the registry are indexed under Tooth Wear; 12 are open to participants now.
This study's planned enrollment of 28 is below the median of 49 across 41 interventional studies indexed under Tooth Wear.
Browse Tooth Wear studies →Biruni University is the lead sponsor of 180 studies on the registry; 45 are open to participants now.
Compared within Tooth Wear, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Tooth Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
per os 2 g augmentin one hour prior to surgery
Procedure: Surgical crown lengthening · Drug: Augmentin
per os placebo one hour prior to surgery
Procedure: Surgical crown lengthening
Surgical clinical crown lengthening with bone excision
Pre-operative antibiotic prophylaxis (2 g Augmentin)
Early healing index (inflammation phase)
Scores are given as specified below (Hamzani et al. 2018) Bleeding (spontaneous or provoked) Yes: 0; No: 1 Granulation tissue Yes: 0; No: 1 Hematoma Yes: 0; No: 1 Tissue color Redder or whiter than opposite site: 0; Similar to opposite site: 1 Incision margins Incomplete flap closure/fibrin clot/partial or complete necrosis: 0; Complete closure/fine fibrin line: 1 Suppuration Yes: 0; No: 1 Edema VAS 6-10: 0; VAS 1-5: 1 Pain VAS 6-10: 0; VAS 1-5: 1
Time frame: at 3 days
Early healing index (proliferation phase)
Scores are given as specified below (Hamzani et al. 2018) Re-epithelization Partial: 0; Complete: 1 Tissue color Redder or whiter than opposite site: 0; Similar to opposite site: 1 Scar wider than 2 mm/contour irregularity: 0; scar less than 2 mm/contour regularity: 1 Suppuration Yes: 0; No: 1 Pain VAS 6-10: 0; VAS 1-5: 1
Time frame: at 10 days
Early healing index (remodeling phase)
Scores are given as specified below (Hamzani et al. 2018) Tissue color Redder or whiter than opposite site: 0; Similar to opposite site: 1 Scar wider than 2 mm/contour irregularity: 0; scar less than 2 mm/contour regularity: 1 Pain VAS 6-10: 0; VAS 1-5: 1
Time frame: at 6 weeks
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Aug 2023; primary completion for Oct 2023, 2 months later.
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This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Amoxicillin-Potassium Clavulanate Combination