Gingival RecessionNCT03095378
Evaluation of Root Coverage by Connective Graft and Different Root Conditioning Methods
A study testing citric acid plus tetracycline and antimicrobial photodynamic therapy in people with Gingival Recession, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The aim of this study was to evaluate the effect of two root-conditioning agents used in conjunction with subepithelial connective graft technique on root coverage outcomes. One is citric acid plus tetracycline and the other is antimicrobial photodynamic therapy. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- citric acid plus tetracycline and antimicrobial photodynamic therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Mar 2014to 10 Mar 2017
- Phase
- Interventional
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Gingival recession - Miller's class I or II (2 to 5 mm of height) at least in one tooth
- Indication of root coverage by dentin hypersensitivity or esthetic
Who cannot join
- Smokers
- Pregnancy
- Systemic medication use that could impair wound healing or surgery procedure
- Systemic diseases as diabetes, uncontrolled hypertension, coagulation diseases, kidney diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Root Coverage by Subepithelial Connective Graft Associated to Root Conditioning by Citric Acid Plus Tetracycline and Antimicrobial Photodynamic Therapy: A Randomized Clinical Trial
The aim of this study was to evaluate the effect of two root-conditioning agents used in conjunction with subepithelial connective graft technique on root coverage outcomes. One is citric acid plus tetracycline and the other is antimicrobial photodynamic therapy.
Read the detailed description
Citric acid plus tetracycline has properties of root surface decontamination, surface demineralization and exposure of collagen fibers.
Antimicrobial photodynamic therapy has been widely used in Periodontics to obtain reduction of periodontopathogenic bacteria with absence of systemic side effects and minimal bacterial resistance. Also, it has properties of root demineralization and exposure of collagen fibers. These properties may enhance root coverage in procedures of subepithelial connective graft.
- Conditions
- Gingival Recession
- Being tested
- Control, citric acid plus tetracycline, antimicrobial photodynamic therapy
- Keywords
- gingival recession
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlProcedure or surgery
Periodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with scaling and root planing
citric acid plus tetracyclineProcedure or surgery
Periodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with citric acid plus tetracycline
antimicrobial photodynamic therapyProcedure or surgery
Periodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with antimicrobial photodynamic therapy
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Root treatment with scaling and root planing. Receives: Procedure: Control |
| Citric acid plus tetracycline | Experimental | Root treatment with 50% citric acid plus 10% tetracycline, pH1, passive application for 90s. Receives: Procedure: citric acid plus tetracycline |
| Antimicrobial photodynamic therapy | Experimental | Antimicrobial photodynamic therapy with toluidine blue O (100ug/ml - 60s pre-irradiation - pH4) and red laser (660nm, 30 milliwatts, 45 joules per square centimeter, sweeping mode, 90s) Receives: Procedure: antimicrobial photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total root coverage measured with a periodontal probe in mm
Distance from cemento-enamel junction to gingival margin = 0 mm
Measured: one year
Secondary outcomes (2)
Keratinized mucosa width measured with a periodontal probe in mm
Ideal if keratinized mucosa width > 5mm
Measured: one year
Dentin hypersensitivity measured by applying an air jet on teeth and patient fills up a visual analogue scale
Ideal if scale = 0
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start10 Mar 2014
- Primary completion10 Feb 2017
- Study completion10 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventions in different patients
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carla Andreotti Damante, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095378
- Sponsor's protocol ID
- BauruSchoolDentistryPDT
- Status last verified
- Mar 2017
- First submitted
- 23 Mar 2017
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Damante CA, Ducati P, Ferreira R, Salmeron S, Zangrando MSR, de Rezende MLR, Sant'Ana ACP, Greghi SLA, Magalhaes AC. In vitro evaluation of adhesion/proliferation of human gingival fibroblasts on demineralized root surfaces by toluidine blue O in antimicrobial photodynamic therapy. Photodiagnosis Photodyn Ther. 2016 Mar;13:303-307. doi: 10.1016/j.pdpdt.2015.08.009. Epub 2015 Sep 7.
PubMed 26358636Karam PS, Sant'Ana AC, de Rezende ML, Greghi SL, Damante CA, Zangrando MS. Root surface modifiers and subepithelial connective tissue graft for treatment of gingival recessions: a systematic review. J Periodontal Res. 2016 Apr;51(2):175-85. doi: 10.1111/jre.12296. Epub 2015 Jun 11.
PubMed 26095265
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Root Coverage by Subepithelial Connective Graft Associated to Root Conditioning by Citric Acid Plus Tetracycline and Antimicrobial Photodynamic Therapy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03095378
- Acronym / sponsor ID
- BauruSchoolDentistryPDT
- Conditions
- Gingival Recession
- Keywords
- gingival recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 10 Mar 2014 (actual)
- Primary completion
- 10 Feb 2017 (actual)
- Study completion
- 10 Mar 2017 (actual)
- First posted
- 29 Mar 2017 (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 aim of this study was to evaluate the effect of two root-conditioning agents used in conjunction with subepithelial connective graft technique on root coverage outcomes. One is citric acid plus tetracycline and the other is antimicrobial photodynamic therapy.
Detailed description
Citric acid plus tetracycline has properties of root surface decontamination, surface demineralization and exposure of collagen fibers.
Antimicrobial photodynamic therapy has been widely used in Periodontics to obtain reduction of periodontopathogenic bacteria with absence of systemic side effects and minimal bacterial resistance. Also, it has properties of root demineralization and exposure of collagen fibers. These properties may enhance root coverage in procedures of subepithelial connective graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Interventions in different patients
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: ControlRoot treatment with scaling and root planing. |
| Citric acid plus tetracycline | Experimental | Procedure: citric acid plus tetracyclineRoot treatment with 50% citric acid plus 10% tetracycline, pH1, passive application for 90s. |
| Antimicrobial photodynamic therapy | Experimental | Procedure: antimicrobial photodynamic therapyAntimicrobial photodynamic therapy with toluidine blue O (100ug/ml - 60s pre-irradiation - pH4) and red laser (660nm, 30 milliwatts, 45 joules per square centimeter, sweeping mode, 90s) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Gingival recession - Miller's class I or II (2 to 5 mm of height) at least in one tooth
- Indication of root coverage by dentin hypersensitivity or esthetic
Key exclusion criteria (4 listed)
- Smokers
- Pregnancy
- Systemic medication use that could impair wound healing or surgery procedure
- Systemic diseases as diabetes, uncontrolled hypertension, coagulation diseases, kidney diseases.
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 |
|---|---|---|
| ControlPeriodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with scaling and root planing | Procedure or surgery | Control |
| citric acid plus tetracyclinePeriodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with citric acid plus tetracycline | Procedure or surgery | Citric acid plus tetracycline |
| antimicrobial photodynamic therapyPeriodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with antimicrobial photodynamic therapy | Procedure or surgery | Antimicrobial photodynamic therapy |
Primary outcome
Total root coverage measured with a periodontal probe in mm
Time frame: one year
Distance from cemento-enamel junction to gingival margin = 0 mm
2 secondary outcomes
Keratinized mucosa width measured with a periodontal probe in mm
Time frame: one year
Dentin hypersensitivity measured by applying an air jet on teeth and patient fills up a visual analogue scale
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Background: PubMed 26358636Damante CA, Ducati P, Ferreira R, Salmeron S, Zangrando MSR, de Rezende MLR, Sant'Ana ACP, Greghi SLA, Magalhaes AC. In vitro evaluation of adhesion/proliferation of human gingival fibroblasts on demineralized root surfaces by toluidine blue O in antimicrobial photodynamic therapy. Photodiagnosis Photodyn Ther. 2016 Mar;13:303-307. doi: 10.1016/j.pdpdt.2015.08.009. Epub 2015 Sep 7.
- Background: PubMed 26095265Karam PS, Sant'Ana AC, de Rezende ML, Greghi SL, Damante CA, Zangrando MS. Root surface modifiers and subepithelial connective tissue graft for treatment of gingival recessions: a systematic review. J Periodontal Res. 2016 Apr;51(2):175-85. doi: 10.1111/jre.12296. Epub 2015 Jun 11.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing citric acid plus tetracycline and antimicrobial photodynamic therapy in people with Gingival Recession, run by University of Sao Paulo at 1 site in Brazil.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total root coverage measured with a periodontal probe in mm (time frame: one year). 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 NCT03095378, which also lists 2 linked publications.
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 29 Mar 2017.