Free Gingival GraftNCT05729919
Healing Dynamics of Free Gingival Grafts; a Colorimetric and Volumetric Assessment
A study testing Free gingival graft technique in people with Free Gingival Graft, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
Gingival recession on vestibular surfaces of teeth is a frequent occurrence in patients with high standards of oral hygiene, affecting all types of teeth. During the last three decades, several surgical techniques have been proposed to treat single and multiple gingival recessions: pedicled flaps (laterally displaced… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Free Gingival Graft
- What is being tested?
- Free gingival graft technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 16 Feb 2021to 24 Apr 2023
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients between 18 and 90 years old
- Patients exhibiting deficient KT and indicated for FGG procedure (28)
- Good systemic health with absence of active periodontal disease
- Plaque and bleeding index <20%
Who cannot join
- Uncontrolled systemic disease
- Heavy smokers (> 10 cigarettes per day)
- Restorations that cannot be removed for proper treatment
- Pregnant or lactant women
Trial locations and contacts
1 site in 1 country.
About this study
Gingival recession on vestibular surfaces of teeth is a frequent occurrence in patients with high standards of oral hygiene, affecting all types of teeth. During the last three decades, several surgical techniques have been proposed to treat single and multiple gingival recessions: pedicled flaps (laterally displaced (CDL) or coronally advanced (ACC) flaps), free gingival grafts (IGL), bilaminar techniques or procedures regenerative.
Read the detailed description
One month before surgery, an interview and periodontal therapy (pre-surgical prophylaxis, oral hygiene instructions and brushing technique teaching) will be carried out.
A digital scan of the arch with the teeth to be treated will be made before the surgery, during the surgery (recipient bed and with sutures), at 6 weeks, 3 months, 6 months and 1 year.
On the day of surgery, the recipient bed will be prepared and a free gingival graft will be taken from the palate to cover the exposed root surface or gain keratinized gingiva.
In terms of aesthetics, morbidity and satisfaction will be evaluated through questions.
At 6 weeks, 3 months, 6 months and 1year, the color of the gum will be evaluated using a spectrophotometer.
- Conditions
- Free Gingival Graft
- Being tested
- Free gingival graft technique
- Keywords
- FGG, Volume, Color
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free gingival graft techniqueProcedure or surgery
A horizontal partial thickness incision will be trace at the MGJ to dissect the alveolar mucosa from the keratinized tissue. The alveolar mucosa will be dissected from the underlying periosteum to create an envelope of 4-5 mm apical to the bone dehiscence associated with the gingival recessions. The keratinized tissue coronal to the first incision and neighboring the recession will be de-epithelialized to expose the connective tissue and create a trapezoidal recipient bed having a large apical base at the MGJ and a narrower coronal base just coronal to the CEJ of the experimental units. The grafts will be taken from the palate.The grafts will be positionned with the coronal edge of the CEJ.
Interrupted sutures (6-0 polypropylene, prolene) will be positionned to stabilize the graft. Sling crossed sutures anchored to the periosteum apical to the graft and placed to ensure a tight adaptation of the graft to the root surface
| Study group | Role | What they receive |
|---|---|---|
| Free gingival graft | Experimental | Free gingival technique will be done Receives: Procedure: Free gingival graft technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric changes of keratinized tissue (KT) around teeth after free gingival graft (FGG).
A digital scan of the arch will be performed with an optical 3D measurement system (3Shape Trios) creating STL files. The corresponding reference and follow-up examinations of each clinical case will be virtually overlaid and combined into a common coordinate system (Geomagic, 3D Systems) using the Control X tool. By using of the buccal surfaces of the affected teeth as reference points for the superposition of the different time points
Measured: 6 weeks, 3 months, 6 months, 1 year
Colorimetric changes of keratinized tissue (KT) around teeth after free gingival
A spectrophotometer (Easy Shade, VITA) will be used for the evaluation of the gingiva color. Before each measurement, the camera will be calibrated. To objectively measure gingiva discoloration, spectrophotometric measurements of the buccal gingiva will be performed on the study and on the adjacent untreated control tooth. The spectrophotometer camera will be positioned perpendicular to the mid-buccal gum and two images will be captured at each site.The center of the area of interest will be located 1.5 mm apical to the mid-buccal gingival margin and 3 mm.
The spectral analysis will generate the CIE-Lab (Commission Internationale d'Eclairage) color coordinates L: luminosity, a: chroma along the red-green axis and b: chroma along the yellow-blue axis. The total color difference DE between the gingiva will be calculated according to the formula DE = [(Limpl Lcontr) 2 + (aimpl acontr) 2 + (bimpl bcontr) 2] 1/2 (CIE 2004)
Measured: 6 weeks, 3 months, 6 months, 1 year
Secondary outcomes (2)
Influence of the volume of an FGG on the color changes
A spectrophotometer (Easy Shade, VITA) will be used for the evaluation of the gingiva color. Before each measurement, the camera will be calibrated. To objectively measure gingiva discoloration, spectrophotometric measurements of the buccal gingiva will be performed on the study and on the adjacent untreated control tooth. The spectrophotometer camera will be positioned perpendicular to the mid-buccal gum and two images will be captured at each site.The center of the area of interest will be located 1.5 mm apical to the mid-buccal gingival margin and 3 mm.
The spectral analysis will generate the CIE-Lab (Commission Internationale d'Eclairage) color coordinates L: luminosity, a: chroma along the red-green axis and b: chroma along the yellow-blue axis. The total color difference DE between the gingiva will be calculated according to the formula DE = [(Limpl Lcontr) 2 + (aimpl acontr) 2 + (bimpl bcontr) 2] 1/2 (CIE 2004)
Measured: 6 weeks, 3 months, 6 months, 1 year
Influence of the volume of an FGG on the contraction of the keratinized gingiva
Influence of the volume of an FGG on the contraction of the keratinized gingiva being evaluated with intraoral scans (IS) A digital scan of the arch will be performed with an optical 3D measurement system (3Shape Trios) creating STL files. The corresponding reference and follow-up examinations of each clinical case will be virtually overlaid and combined into a common coordinate system (Geomagic, 3D Systems) using the Control X tool. By using of the buccal surfaces of the affected teeth as reference points for the superposition of the different time points
Measured: 6 weeks, 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start16 Feb 2021
- Primary completion12 Mar 2021
- Study completion24 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Free Gingival GraftStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonzalo Blasi, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729919
- Sponsor's protocol ID
- PER-ECL-2020-08
- Status last verified
- May 2023
- First submitted
- 13 Jan 2023
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Dynamics of Free Gingival Grafts; a Colorimetric and Volumetric Assessment
- ClinicalTrials.gov ID
- NCT05729919
- Acronym / sponsor ID
- PER-ECL-2020-08
- Conditions
- Free Gingival Graft
- Keywords
- FGG, Volume, Color
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 15 Feb 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.
Gingival recession on vestibular surfaces of teeth is a frequent occurrence in patients with high standards of oral hygiene, affecting all types of teeth. During the last three decades, several surgical techniques have been proposed to treat single and multiple gingival recessions: pedicled flaps (laterally displaced (CDL) or coronally advanced (ACC) flaps), free gingival grafts (IGL), bilaminar techniques or procedures regenerative.
Detailed description
One month before surgery, an interview and periodontal therapy (pre-surgical prophylaxis, oral hygiene instructions and brushing technique teaching) will be carried out.
A digital scan of the arch with the teeth to be treated will be made before the surgery, during the surgery (recipient bed and with sutures), at 6 weeks, 3 months, 6 months and 1 year.
On the day of surgery, the recipient bed will be prepared and a free gingival graft will be taken from the palate to cover the exposed root surface or gain keratinized gingiva.
In terms of aesthetics, morbidity and satisfaction will be evaluated through questions.
At 6 weeks, 3 months, 6 months and 1year, the color of the gum will be evaluated using a spectrophotometer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Free gingival graft | Experimental | Procedure: Free gingival graft techniqueFree gingival technique will be done |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients between 18 and 90 years old
- Patients exhibiting deficient KT and indicated for FGG procedure (28)
- Good systemic health with absence of active periodontal disease
- Plaque and bleeding index <20%
Key exclusion criteria (4 listed)
- Uncontrolled systemic disease
- Heavy smokers (> 10 cigarettes per day)
- Restorations that cannot be removed for proper treatment
- Pregnant or lactant women
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 graft techniqueA horizontal partial thickness incision will be trace at the MGJ to dissect the alveolar mucosa from the keratinized tissue. The alveolar mucosa will be dissected from the underlying periosteum to create an envelope of 4-5 mm apical to the bone dehiscence associated with the gingival recessions. The keratinized tissue coronal to the first incision and neighboring the recession will be de-epithelialized to expose the connective tissue and create a trapezoidal recipient bed having a large apical base at the MGJ and a narrower coronal base just coronal to the CEJ of the experimental units. The grafts will be taken from the palate.The grafts will be positionned with the coronal edge of the CEJ. Interrupted sutures (6-0 polypropylene, prolene) will be positionned to stabilize the graft. Sling crossed sutures anchored to the periosteum apical to the graft and placed to ensure a tight adaptation of the graft to the root surface | Procedure or surgery | Free gingival graft |
Primary outcome
Volumetric changes of keratinized tissue (KT) around teeth after free gingival graft (FGG).
Time frame: 6 weeks, 3 months, 6 months, 1 year
A digital scan of the arch will be performed with an optical 3D measurement system (3Shape Trios) creating STL files. The corresponding reference and follow-up examinations of each clinical case will be virtually overlaid and combined into a common coordinate system (Geomagic, 3D Systems) using the Control X tool. By using of the buccal surfaces of the affected teeth as reference points for the superposition of the different time points
Colorimetric changes of keratinized tissue (KT) around teeth after free gingival
Time frame: 6 weeks, 3 months, 6 months, 1 year
A spectrophotometer (Easy Shade, VITA) will be used for the evaluation of the gingiva color. Before each measurement, the camera will be calibrated. To objectively measure gingiva discoloration, spectrophotometric measurements of the buccal gingiva will be performed on the study and on the adjacent untreated control tooth. The spectrophotometer camera will be positioned perpendicular to the mid-buccal gum and two images will be captured at each site.The center of the area of interest will be located 1.5 mm apical to the mid-buccal gingival margin and 3 mm. The spectral analysis will generate the CIE-Lab (Commission Internationale d'Eclairage) color coordinates L: luminosity, a: chroma along the red-green axis and b: chroma along the yellow-blue axis. The total color difference DE between the gingiva will be calculated according to the formula DE = [(Limpl Lcontr) 2 + (aimpl acontr) 2 + (bimpl bcontr) 2] 1/2 (CIE 2004)
2 secondary outcomes
Influence of the volume of an FGG on the color changes
Time frame: 6 weeks, 3 months, 6 months, 1 year
Influence of the volume of an FGG on the contraction of the keratinized gingiva
Time frame: 6 weeks, 3 months, 6 months, 1 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 10 May 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.
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 Free gingival graft technique in people with Free Gingival Graft, run by Universitat Internacional de Catalunya at 1 site in Spain.
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 4 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 10 May 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 Spain. 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?
Volumetric changes of keratinized tissue (KT) around teeth after free gingival graft (FGG). (time frame: 6 weeks, 3 months, 6 months, 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2023.