Tooth Diseases, Tooth Wear
Conditions
Brief summary
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 * 2 g of amoxicillin + clavulanate, or * placebo, one hour prior to surgery and without knowing what medicine they took. Researchers will compare the wound healing and self-reported outcomes of the antibiotics group and placebo group.
Interventions
PROCEDURESurgical crown lengthening
Surgical clinical crown lengthening with bone excision
DRUGAugmentin
Pre-operative antibiotic prophylaxis (2 g Augmentin)
Sponsors
Biruni University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* in need of surgical crown lengthening operation in one/two teeth
Exclusion criteria
* systemic diseases which may affect periodontal tissues and/or healing process such as diabetes mellitus * antibiotic or anti-inflammatory drug use in the last 3 months * pregnancy/lactation * chronic steroid, immunosuppressant or NSAD use * age \<18 years * positive bleeding on probing at the surgical site and/or active periodontal disease * \<2 mm keratinized mucosa at the surgical site following surgery (estimated surgical outcome before the operation) * Miller 2 or 3 tooth mobility * penicillin allergy * unwilling to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early healing index (inflammation phase) | at 3 days | 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 |
| Early healing index (proliferation phase) | at 10 days | 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 |
| Early healing index (remodeling phase) | at 6 weeks | 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 |
Contacts
Primary ContactMustafa YILMAZ, PhD, DDS
Backup ContactAyse Ege Selman, DDS
Outcome results
None listed