Tooth DiseasesPhase 4SCLABPNCT05925179
Effects of Antibiotic Prophylaxis on the Healing Parameters Following Surgical Crown Lengthening
A Phase 4 study testing Surgical crown lengthening and Augmentin in people with Tooth Diseases and Tooth Wear, run by Biruni University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Diseases, Tooth Wear
- What is being tested?
- Surgical crown lengthening and Augmentin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 Jan 2024
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- in need of surgical crown lengthening operation in one/two teeth
Who cannot join
- 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
Show all 10Show fewer
- <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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Pre-operative Antibiotics on the Wound Healing Following Clinical Crown Lengthening Surgery
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.
- Conditions
- Tooth Diseases, Tooth Wear
- Being tested
- Surgical crown lengthening, Augmentin
- Medical subject headings
- Tooth Diseases, Tooth Wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical crown lengtheningProcedure or surgery
Surgical clinical crown lengthening with bone excision
AugmentinDrug
Pre-operative antibiotic prophylaxis (2 g Augmentin)
| Study group | Role | What they receive |
|---|---|---|
| antibiotic prophylaxis | Experimental | per os 2 g augmentin one hour prior to surgery Receives: Procedure: Surgical crown lengthening; Drug: Augmentin |
| placebo control | Placebo comparator | per os placebo one hour prior to surgery Receives: Procedure: Surgical crown lengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth DiseasesStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa YILMAZ, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925179
- Sponsor's protocol ID
- Antibiotics crown lengthening
- Acronym
- SCLABP
- Status last verified
- Jul 2023
- First submitted
- 21 Jun 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hamzani Y, Chaushu G. Evaluation of early wound healing scales/indexes in oral surgery: A literature review. Clin Implant Dent Relat Res. 2018 Dec;20(6):1030-1035. doi: 10.1111/cid.12680. Epub 2018 Oct 15.
PubMed 30324746
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pre-operative Antibiotics on the Wound Healing Following Clinical Crown Lengthening Surgery
- ClinicalTrials.gov ID
- NCT05925179
- Acronym / sponsor ID
- SCLABP / Antibiotics crown lengthening
- Conditions
- Tooth Diseases, Tooth Wear
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 29 Jun 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antibiotic prophylaxis | Experimental | Procedure: Surgical crown lengthening, Drug: Augmentinper os 2 g augmentin one hour prior to surgery |
| placebo control | Placebo comparator | Procedure: Surgical crown lengtheningper os placebo one hour prior to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- in need of surgical crown lengthening operation in one/two teeth
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Surgical crown lengtheningSurgical clinical crown lengthening with bone excision | Procedure or surgery | antibiotic prophylaxis, placebo control |
| AugmentinPre-operative antibiotic prophylaxis (2 g Augmentin) | Drug | antibiotic prophylaxis |
Primary outcome
Early healing index (inflammation phase)
Time frame: 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)
Time frame: 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)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Background: PubMed 30324746Hamzani Y, Chaushu G. Evaluation of early wound healing scales/indexes in oral surgery: A literature review. Clin Implant Dent Relat Res. 2018 Dec;20(6):1030-1035. doi: 10.1111/cid.12680. Epub 2018 Oct 15.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Surgical crown lengthening and Augmentin in people with Tooth Diseases and Tooth Wear, run by Biruni University.
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 1 inclusion and 10 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 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Mustafa YILMAZ, PhD, DDS (+902124440276, myilmaz@biruni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early healing index (inflammation phase) (time frame: at 3 days). The study lists 3 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 NCT05925179, which also lists 1 linked publication.
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 19 Jul 2023.