Gingival RecessionEFFECTNCT02613702
Efficacy of a Modified Technique of Free Gingival Graft in Volumetric Changes of the Graft: Randomized Clinical Trial
A study testing Free Gingival Graft, Original Free Gingival Graft technique and Modified Free Gingival Graft technique in people with Gingival Recession, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study will compare a new technique of free gingival graft to the original one, in order to evaluate the stability of the graft volume over one year and other variables. Twenty patients will receive the original technique of free gingival graft (controls) and twenty patients will receive the modified technique, in… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Free Gingival Graft, Original Free Gingival Graft technique and Modified Free Gingival Graft technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2015to Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Reduced keratinized tissue (less than 2 mm) in inferior incisors area
- Healthy periodontium in inferior incisors area
- Indication for surgery (e.g. pain during tooth brushing, gingival margin mobility, gingival recession...)
- Recessions class I, II or III, maximum 3 mm
- Having signed the informed consent
Who cannot join
- Systemic diseases
- Smokers
- Pregnant and lactating women
- Root caries lesions
- Previous surgeries at same area
- Accentuated root abrasion
Show all 9Show fewer
- Malpositioning teeth
- Residual pocket depths greater than 4 mm
- Tooth mobility greater than 1
Trial locations and contacts
1 site in 1 country.
About this study
This study will compare a new technique of free gingival graft to the original one, in order to evaluate the stability of the graft volume over one year and other variables. Twenty patients will receive the original technique of free gingival graft (controls) and twenty patients will receive the modified technique, in which the free gingival graft is submerged (tests), at the inferior incisors area.
Read the detailed description
The free gingival graft surgery is held to gain some keratinized tissue in areas where it has been lost, such as in inferior incisors with gingival recessions. In these areas, tooth brushing may become harder and painful, negatively influencing in plaque control. However, this type of graft seems to contract over time. A new approach of free gingival graft, in which the graft is covered by a flap, promises to provide greater vascularization. This would promote less graft contraction and better mucosal color. Forty patients with less than 2 mm of keratinized tissue (measured from gingival margin to mucogingival junction) in at least one inferior incisor will be included. Half will receive the original technique and half will receive the modified one. Patients will be followed at 7, 14, 21, 28, 42 days, 3, 6, 12 months and 8 years after surgeries.
- Conditions
- Gingival Recession
- Being tested
- Free Gingival Graft, Original Free Gingival Graft technique, Modified Free Gingival Graft technique
- Keywords
- Free gingival graft, keratinized gingival tissue
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free Gingival GraftProcedure or surgery
Surgical technique (autologous graft): Free gingival graft technique, harvested from palate.
Original Free Gingival Graft techniqueProcedure or surgery
Surgical technique (autologous graft): Original technique of free gingival graft, positioned at the inferior incisors area at the donor area
Modified Free Gingival Graft techniqueProcedure or surgery
Surgical technique (autologous graft): Free gingival graft. positioned at the inferior incisors area and covered by a flap at the donor area
| Study group | Role | What they receive |
|---|---|---|
| Modified Free Gingival Graft | Experimental | Twenty patients will receive the modified free gingival graft technique at the inferior incisors area. In this technique, the graft is covered by a flap, similarly to what is done in a connective tissue graft surgery. Receives: Procedure: Free Gingival Graft; Procedure: Modified Free Gingival Graft technique |
| Original Free Gingival Graft technique | Active comparator | Twenty patients will receive the original technique of free gingival graft at the inferior incisors area. Receives: Procedure: Free Gingival Graft; Procedure: Original Free Gingival Graft technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apical-cervical width of keratinized tissue after 12 months
Distance between gingival margin and mucogingival junction, in millimeters
Measured: 12 months
Secondary outcomes (11)
Probing Depth
Distance between gingival margin and bottom of the sulcus / pocket, in millimeters
Measured: 12 months
Keratinized tissue area
Keratinized tissue area, measured in millimeters
Measured: 12 months
Keratinized tissue thickness
Keratinized tissue thickness measured in millimeters
Measured: 12 months
Volume of receiving area
Volume of receiving area
Measured: 12 months
Complete epithelization of donor area
Area of Epithelization of wound healing, measured in mm2
Measured: 28 days
Postoperative discomfort
discomfort measured using Visual Analogue Scale
Measured: 28 days
Gum color
Measured with photographic analysis
Measured: 12 months
Oral Health Related Quality of Life (OHIP)
OHIp - 14 short version
Measured: 12 months
Clinical Attachment Level
Distance between cementum-enamel junction and bottom of sulcus / pocket, measured in millimeters
Measured: 12 months
Recession
Distance between cementum-enamel junction and gingival margin, measured in millimeters
Measured: 12 months
Bleeding on probing
percentage of sites which bled upon probing
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionMay 2025
- Study completionJul 2025 (estimated)
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.
- More trials run by University of Sao PauloThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Estadual de Maringá
- Responsible party
- Principal investigator, Claudio Mendes Pannuti, University of Sao Paulo
- Investigators
- Claudio M Pannuti, PhD, Principal investigator, University of Sao PauloJoão Batista C Neto, PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613702
- Sponsor's protocol ID
- EFFECT
- Acronym
- EFFECT
- Status last verified
- May 2025
- First submitted
- 18 Nov 2015
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Cesar Neto JB, Cavalcanti MC, Silva CO, Almeida VC, Sapata VM, Lazarin RO, Jung R, Romito GA, Tatakis DN, Pannuti CM. Digital three-dimensional assessment of free gingival graft remodeling over 12 months. J Dent. 2024 Sep;148:105216. doi: 10.1016/j.jdent.2024.105216. Epub 2024 Jun 29.
PubMed 38950768Almeida VC, Pannuti CM, Ferreira MS, Lazarin RO, Romito GA, Jung RE, Tatakis DN, Silva COE, Cesar Neto JB. Conventional versus flap-protected free gingival graft: a multicenter randomized clinical trial. Braz Oral Res. 2023 Jan 6;37:e001. doi: 10.1590/1807-3107bor-2023.vol37.0001. eCollection 2023.
PubMed 36629587
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Modified Technique of Free Gingival Graft in Volumetric Changes of the Graft: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02613702
- Acronym / sponsor ID
- EFFECT / EFFECT
- Conditions
- Gingival Recession
- Keywords
- Free gingival graft, keratinized gingival tissue
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Universidade Estadual de Maringá
- Study start
- Sep 2015 (actual)
- Primary completion
- May 2025 (actual)
- Study completion
- Jul 2025 (estimated)
- First posted
- 24 Nov 2015 (estimated)
- 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.
This study will compare a new technique of free gingival graft to the original one, in order to evaluate the stability of the graft volume over one year and other variables. Twenty patients will receive the original technique of free gingival graft (controls) and twenty patients will receive the modified technique, in which the free gingival graft is submerged (tests), at the inferior incisors area.
Detailed description
The free gingival graft surgery is held to gain some keratinized tissue in areas where it has been lost, such as in inferior incisors with gingival recessions. In these areas, tooth brushing may become harder and painful, negatively influencing in plaque control. However, this type of graft seems to contract over time. A new approach of free gingival graft, in which the graft is covered by a flap, promises to provide greater vascularization. This would promote less graft contraction and better mucosal color. Forty patients with less than 2 mm of keratinized tissue (measured from gingival margin to mucogingival junction) in at least one inferior incisor will be included. Half will receive the original technique and half will receive the modified one. Patients will be followed at 7, 14, 21, 28, 42 days, 3, 6, 12 months and 8 years after surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Free Gingival Graft | Experimental | Procedure: Free Gingival Graft, Procedure: Modified Free Gingival Graft techniqueTwenty patients will receive the modified free gingival graft technique at the inferior incisors area. In this technique, the graft is covered by a flap, similarly to what is done in a connective tissue graft surgery. |
| Original Free Gingival Graft technique | Active comparator | Procedure: Free Gingival Graft, Procedure: Original Free Gingival Graft techniqueTwenty patients will receive the original technique of free gingival graft at the inferior incisors area. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Reduced keratinized tissue (less than 2 mm) in inferior incisors area
- Healthy periodontium in inferior incisors area
- Indication for surgery (e.g. pain during tooth brushing, gingival margin mobility, gingival recession...)
- Recessions class I, II or III, maximum 3 mm
- Having signed the informed consent
Key exclusion criteria (9 listed)
- Systemic diseases
- Smokers
- Pregnant and lactating women
- Root caries lesions
- Previous surgeries at same area
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 |
|---|---|---|
| Free Gingival GraftSurgical technique (autologous graft): Free gingival graft technique, harvested from palate. | Procedure or surgery | Modified Free Gingival Graft, Original Free Gingival Graft technique |
| Original Free Gingival Graft techniqueSurgical technique (autologous graft): Original technique of free gingival graft, positioned at the inferior incisors area at the donor area | Procedure or surgery | Original Free Gingival Graft technique |
| Modified Free Gingival Graft techniqueSurgical technique (autologous graft): Free gingival graft. positioned at the inferior incisors area and covered by a flap at the donor area | Procedure or surgery | Modified Free Gingival Graft |
Primary outcome
Apical-cervical width of keratinized tissue after 12 months
Time frame: 12 months
Distance between gingival margin and mucogingival junction, in millimeters
11 secondary outcomes
Probing Depth
Time frame: 12 months
Keratinized tissue area
Time frame: 12 months
Keratinized tissue thickness
Time frame: 12 months
Volume of receiving area
Time frame: 12 months
Complete epithelization of donor area
Time frame: 28 days
Postoperative discomfort
Time frame: 28 days
Gum color
Time frame: 12 months
Oral Health Related Quality of Life (OHIP)
Time frame: 12 months
Clinical Attachment Level
Time frame: 12 months
Recession
Time frame: 12 months
Bleeding on probing
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Results publication: PubMed 38950768Cesar Neto JB, Cavalcanti MC, Silva CO, Almeida VC, Sapata VM, Lazarin RO, Jung R, Romito GA, Tatakis DN, Pannuti CM. Digital three-dimensional assessment of free gingival graft remodeling over 12 months. J Dent. 2024 Sep;148:105216. doi: 10.1016/j.jdent.2024.105216. Epub 2024 Jun 29.
- Results publication: PubMed 36629587Almeida VC, Pannuti CM, Ferreira MS, Lazarin RO, Romito GA, Jung RE, Tatakis DN, Silva COE, Cesar Neto JB. Conventional versus flap-protected free gingival graft: a multicenter randomized clinical trial. Braz Oral Res. 2023 Jan 6;37:e001. doi: 10.1590/1807-3107bor-2023.vol37.0001. eCollection 2023.
- 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.
Claudio M Pannuti, PhD principal investigator
University of Sao Paulo
João Batista C Neto, PhD study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free Gingival Graft, Original Free Gingival Graft technique and Modified Free Gingival Graft technique 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 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: under way, not looking for participants, as of the sponsor's last update on 25 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Apical-cervical width of keratinized tissue after 12 months (time frame: 12 months). 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 NCT02613702, 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 25 May 2025.