Gingival RecessionNCT03462368
Evaluation of Root Coverage by Connective Graft and Different Root Conditioning Adjunctive Therapies
A study testing antimicrobial photodynamic therapy and Photobiomodulation in people with Gingival Recession and Gingival Recession, Generalized, 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 different treatment agents used in conjunction with subepithelial connective graft technique on root coverage outcomes in multiple recession defects. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gingival Recession, Gingival Recession, Generalized
- What is being tested?
- antimicrobial photodynamic therapy and Photobiomodulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2018to 28 Nov 2019
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Multiple Gingival recession - two or more Miller's class I or II (2 to 5 mm of height)
- Indication of root coverage by dentin hypersensitivity or esthetic.
- Minimum palate thickness (1,5mm)
- Visible Enamel cement junction (JCE) on the teeth to be treated and pulp vitality
- Patients without signs of periodontal disease activity and with plaque index and bleeding on probing throughout ≤20%;
Who cannot join
- Use of drugs that affect periodontal tissues (eg: anticonvulsants, calcium channel blockers, cyclosporine, bisphosphonates, hormone-based contraceptives, steroids)
- Smokers
- Pregnancy
- Diabetics
- History of head and neck radiotherapy
- Teeth with mobility
Show all 9Show fewer
- Malpositioned teeth
- History of periodontal surgery at the area on the last 12 months
- Patients with orthodontic therapy in progression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Photobiomodulation and Antimicrobial Photodynamic Therapy Associated With Subepithelial Connective Tissue Graft on the Root Coverage of Multiple Gingival Recessions: A Randomized Controlled Clinical Trial.
The aim of this study was to evaluate the effect of two different treatment agents used in conjunction with subepithelial connective graft technique on root coverage outcomes in multiple recession defects. Half of patients will receive root treatment with antimicrobial photodynamic therapy and the other half will receive photobiomodulation therapy by laser on surgery site.
Read the detailed description
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. Laser photobiomodulation has the potential to increase healing and repair, this can generate gains in the root coverage and dental hypersensitivity.
- Being tested
- Control, antimicrobial photodynamic therapy, Photobiomodulation
- 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
Also called Scaling and root planing only
In the procedure of subepithelial connective tissue graft, exposed dental roots will be treated by scaling and root planing only.
antimicrobial photodynamic therapyProcedure or surgery
In the procedure of subepithelial connective tissue graft, exposed dental roots will be treated by antimicrobial photodynamic therapy with toluidine blue O (10mg/ml)
PhotobiomodulationProcedure or surgery
Also called Low level laser therapy
After the procedure of subepithelial connective tissue graft the whole surgical site will receive red laser application.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Root surface treatment by scaling and root planing Receives: Procedure: Control |
| antimicrobial photodynamic therapy | Experimental | Root surface treatment by antimicrobial photodynamic therapy Receives: Procedure: antimicrobial photodynamic therapy |
| Photobiomodulation | Active comparator | Treatment of the whole surgical site with laser Receives: Procedure: Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total root coverage
Total root coverage measured with a periodontal probe in millimeters. Ideal if the distance from cemento-enamel junction to gingival margin = 0 mm
Measured: One year
Secondary outcomes (4)
Keratinized mucosa width
Keratinized mucosa width is measured with a periodontal probe in mm, from gingival margin to mucogingival junction. Ideal if keratinized mucosa width > 5mm
Measured: One year
Probing depth
Probing depth measured with a periodontal probe in millimeters. The distance from gingival margin and the apical point of gingival pocket or sulcus. Ideal if <2mm.
Measured: One year
Clinical attachment level
Clinical attachment level measured with a periodontal probe in millimeters. The distance from cemento-enamel junction and the apical point of gingival pocket or sulcus. Ideal if <2mm.
Measured: One year
Dentin hypersensitivity
Dentin hypersensitivity measured by applying an air jet on teeth and patient fills up a visual analogue scale. Ideal if = 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 posted12 Mar 2018
- Study start1 Apr 2018
- Primary completion28 Nov 2019
- Study completion28 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 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
- NCT03462368
- Sponsor's protocol ID
- FOBaPDTrecession
- Status last verified
- Feb 2023
- First submitted
- 28 Feb 2018
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karam 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 26095265Fernandes-Dias SB, de Marco AC, Santamaria M Jr, Kerbauy WD, Jardini MA, Santamaria MP. Connective tissue graft associated or not with low laser therapy to treat gingival recession: randomized clinical trial. J Clin Periodontol. 2015 Jan;42(1):54-61. doi: 10.1111/jcpe.12328. Epub 2014 Dec 17.
PubMed 25363203Anders JJ, Lanzafame RJ, Arany PR. Low-level light/laser therapy versus photobiomodulation therapy. Photomed Laser Surg. 2015 Apr;33(4):183-4. doi: 10.1089/pho.2015.9848. No abstract available.
PubMed 25844681Cardoso MV, Sant'Ana ACP, Zangrando MSR, Damante CA. Effects of photobiostimulation and antimicrobial photodynamic therapy associated with gingival grafts for root coverage: three-arm randomized clinical trial. Lasers Med Sci. 2025 Apr 14;40(1):190. doi: 10.1007/s10103-025-04449-0.
PubMed 40227516
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Photobiomodulation and Antimicrobial Photodynamic Therapy Associated With Subepithelial Connective Tissue Graft on the Root Coverage of Multiple Gingival Recessions: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03462368
- Acronym / sponsor ID
- FOBaPDTrecession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 28 Nov 2019 (actual)
- Study completion
- 28 Nov 2019 (actual)
- First posted
- 12 Mar 2018 (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 different treatment agents used in conjunction with subepithelial connective graft technique on root coverage outcomes in multiple recession defects. Half of patients will receive root treatment with antimicrobial photodynamic therapy and the other half will receive photobiomodulation therapy by laser on surgery site.
Detailed description
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. Laser photobiomodulation has the potential to increase healing and repair, this can generate gains in the root coverage and dental hypersensitivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: ControlRoot surface treatment by scaling and root planing |
| antimicrobial photodynamic therapy | Experimental | Procedure: antimicrobial photodynamic therapyRoot surface treatment by antimicrobial photodynamic therapy |
| Photobiomodulation | Active comparator | Procedure: PhotobiomodulationTreatment of the whole surgical site with laser |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Multiple Gingival recession - two or more Miller's class I or II (2 to 5 mm of height)
- Indication of root coverage by dentin hypersensitivity or esthetic.
- Minimum palate thickness (1,5mm)
- Visible Enamel cement junction (JCE) on the teeth to be treated and pulp vitality
- Patients without signs of periodontal disease activity and with plaque index and bleeding on probing throughout ≤20%;
Key exclusion criteria (9 listed)
- Use of drugs that affect periodontal tissues (eg: anticonvulsants, calcium channel blockers, cyclosporine, bisphosphonates, hormone-based contraceptives, steroids)
- Smokers
- Pregnancy
- Diabetics
- History of head and neck radiotherapy
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 |
|---|---|---|
| ControlAlso: Scaling and root planing onlyIn the procedure of subepithelial connective tissue graft, exposed dental roots will be treated by scaling and root planing only. | Procedure or surgery | Control |
| antimicrobial photodynamic therapyIn the procedure of subepithelial connective tissue graft, exposed dental roots will be treated by antimicrobial photodynamic therapy with toluidine blue O (10mg/ml) | Procedure or surgery | antimicrobial photodynamic therapy |
| PhotobiomodulationAlso: Low level laser therapyAfter the procedure of subepithelial connective tissue graft the whole surgical site will receive red laser application. | Procedure or surgery | Photobiomodulation |
Primary outcome
Total root coverage
Time frame: One year
Total root coverage measured with a periodontal probe in millimeters. Ideal if the distance from cemento-enamel junction to gingival margin = 0 mm
4 secondary outcomes
Keratinized mucosa width
Time frame: One year
Probing depth
Time frame: One year
Clinical attachment level
Time frame: One year
Dentin hypersensitivity
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 27 Feb 2023.
- 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.
- Background: PubMed 25363203Fernandes-Dias SB, de Marco AC, Santamaria M Jr, Kerbauy WD, Jardini MA, Santamaria MP. Connective tissue graft associated or not with low laser therapy to treat gingival recession: randomized clinical trial. J Clin Periodontol. 2015 Jan;42(1):54-61. doi: 10.1111/jcpe.12328. Epub 2014 Dec 17.
- Background: PubMed 25844681Anders JJ, Lanzafame RJ, Arany PR. Low-level light/laser therapy versus photobiomodulation therapy. Photomed Laser Surg. 2015 Apr;33(4):183-4. doi: 10.1089/pho.2015.9848. No abstract available.
- Derived from this study: PubMed 40227516Cardoso MV, Sant'Ana ACP, Zangrando MSR, Damante CA. Effects of photobiostimulation and antimicrobial photodynamic therapy associated with gingival grafts for root coverage: three-arm randomized clinical trial. Lasers Med Sci. 2025 Apr 14;40(1):190. doi: 10.1007/s10103-025-04449-0.
- 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 antimicrobial photodynamic therapy and Photobiomodulation in people with Gingival Recession and Gingival Recession, Generalized, 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 5 inclusion and 9 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 27 Feb 2023. 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 (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 NCT03462368, which also lists 4 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 27 Feb 2023.