Ndirectly Measuring the Difference Between the Free Gingival Graft and the Free Gingival Unit Via a ScannerNCT06101524
Volumetric Changes in Free Gingival Graft Procedures Taken With Different Techniques
A study testing Free gingival unit, free gingival greft in people with Ndirectly Measuring the Difference Between the Free Gingival Graft and the Free Gingival Unit Via a Scanner, run by Eda Cetin Ozdemir at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study is to evaluate the clinical results of free gingival graft and gingival unit graft by indirect method. To evaluate the 6-month results linearly and volumetrically using an intraoral scanner (TRİOS, 3Shape, Copenhagen, Denmark) (using measurements and on a plaster model). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ndirectly Measuring the Difference Between the Free Gingival Graft and the Free Gingival Unit Via a Scanner
- What is being tested?
- Free gingival unit, free gingival greft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 1 Jun 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are systemically healty,
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sütçü İmam University
Kahramanmaraş
About this study
Official title: Digital Evaluation of Volumetric Changes of Free Gingival Graft and Gingival Unit Graft With Indirect Method
The primary aim of this study is to evaluate the clinical results of free gingival graft and gingival unit graft by indirect method.
To evaluate the 6-month results linearly and volumetrically using an intraoral scanner (TRİOS, 3Shape, Copenhagen, Denmark) (using measurements and on a plaster model).
Read the detailed description
Deficiency of keratinized tissue includes mucogingival problems among different clinical entities. (Silva et al., 2010) There is no consensus on the minimum amount of attached gingiva required to maintain the health of the gums. However, there are many clinical situations that demonstrate the necessity of keratinized tissue. (Cevallos et al., 2020) (Agarwal et al., 2015) For example, if the attached gingiva is thin, it becomes difficult to perform adequate oral hygiene procedures and plaque. Inflammation and attachment loss are observed due to accumulation. (Gümüş and Buduneli, 2014) (Raoofi et al., 2019) Keratinized tissue width expresses the distance between the coronal margin of the gingival sulcus and the mucogingival line. It is considered to be the main factor in the management and protection of tissue health around natural teeth. (Agudio et al., 2019) Gingival recession refers to the apical displacement of the soft tissue margin from the cemento-enamel border. Oral hygiene and plaque with tooth sensitivity, root caries, unaesthetic appearance as well as loss of periodontal attachment causes retention. (Arzouman et al., n.d.) (Chambrone and Tatakis, 2015) In the treatment of gingival recession Many techniques have been described: Subepithelial connective tissue graft, stemmed grafts (coronally, laterally), free gingival graft (FGG), gingival unit graft (GUG). (Cevallos et al., 2020)(Sriwil et al., 2020). Although significant results are observed, there are different success rates between techniques. (Sriwil et al., 2020) FGG is used not only to cover the root surface but also to increase the width of keratinized tissue. It was first proposed by Nabers for this purpose. (Mörmann et al., 1981) Currently, the FGG's incompatible aesthetic and crude. It has many limitations due to its appearance. (Sriwil et al., 2020)
Due to the limitations of the FGG, there was a need for a new perspective on such phenomena. The vascular characteristics of the graft are important in terms of rapid capillary anastomosis with impaired vascularity of the recipient site. (Sriwil et al., 2020) Gingival sulcus, where thin blood vessels form a network and capillaries show numerous anastomoses is the place. (Jenabian et al., 2016) The vascular plexus of the gingiva, in terms of horizontal anastomoses feeding the marginal zone marginal and interdental tissues to benefit from better blood perfusion of the recipient area can be used, thus increasing the chances of survival of the graft. (Sriwil et al., 2020) (Yıldırım, 2015) The supracrestal part of the gingiva, which includes the marginal and papillary tissues, is included in the soft tissue graft taken to nourish the avascular root surface.
Studies have shown that the marginal, attached, and interdental gingival regions have significantly different vascular distributions. (Sriwil et al., 2020)
Due to these advantages of marginal and interdental tissues, the technique defined as Gingival Unit Graft (GUG) containing marginal and interdental papilla has emerged as an alternative approach to FGG. (Yıldırım, 2015) Kuru and Yıldırım, in their randomized controlled study comparing FGG and GUG in terms of keratinized tissue gain and root surface coverage, reported that DÜG gave better clinical results. (Dry oath Yıldırım, 2013)
G Power 3.1 (University Kiel, Germany) program was used to calculate the effect size. Effect size Free Gingival Graft in the study of Sriwil, Fakher (1) and an effect size of 2.12 d cohen was determined to be sufficient for significance. It was found that a total of 20 samples, at least 10 for each study group, was sufficient with a type 1 error of 0.05 and 99% power.
Free Gingival Graft was applied to 10 patients with keratinized mucosa deficiency, and Gingival Unit Graft was applied to 10 patients. Volumetric changes in the gingiva were measured both clinically and by scanner at the beginning and 6th months.
- Being tested
- Free gingival unit, free gingival greft
- Keywords
- Free gingival greft, Free gingival unit, Scanner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free gingival unit, free gingival greftProcedure or surgery
The free gingival graft and the free gingival unit taken from the upper jaw palatal mucosa were sutured to the lower jaw anterior region.
| Study group | Role | What they receive |
|---|---|---|
| Free Gingival greft Group | Experimental | Patients who are found to have keratinized mucosa insufficiency as a result of the examination, undergo free gingival graft to increase the keratinized mucosa. procedures will be done and you will be called for a check-up after 6 months.
The keratinized tissue volume formed after the procedure will be evaluated. Receives: Procedure: Free gingival unit, free gingival greft |
| Gingival Unit Greft Group | Experimental | Patients who are found to have keratinized mucosa insufficiency as a result of the examination, undergo gingival unit graft to increase the keratinized mucosa. procedures will be done and you will be called for a check-up after 6 months.
The keratinized tissue volume formed after the procedure will be evaluated. Receives: Procedure: Free gingival unit, free gingival greft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keratinized gingival width
The change in keratinized tissue width after free gingival graft and gingival graft unit operations was evaluated.
Measured: İnitial and postoperative 6 months
Average gingival thickness change (mm)
The change in average gingival thickness change after free gingival graft and gingival graft unit operations was evaluated.
Measured: İnitial and postoperative 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Feb 2022
- Primary completion1 Jan 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Ndirectly Measuring the Difference Between the Free Gingival Graft and the Free Gingival Unit Via a ScannerStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eda Cetin Ozdemir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eda Cetin Ozdemir, Kahramanmaras Sutcu Imam University
- Investigators
- Eda Çetin Özdemir, Study chair, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101524
- Sponsor's protocol ID
- 2022/01-01
- Status last verified
- Oct 2023
- First submitted
- 20 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have other studies using this data
Publications
Agarwal C, Tarun Kumar AB, Mehta DS. Comparative evaluation of free gingival graft and AlloDerm((R)) in enhancing the width of attached gingival: A clinical study. Contemp Clin Dent. 2015 Oct-Dec;6(4):483-8. doi: 10.4103/0976-237X.169838.
PubMed 26681852Agudio G, Chambrone L, Selvaggi F, Pini-Prato GP. Effect of gingival augmentation procedure (free gingival graft) on reducing the risk of non-carious cervical lesions: A 25- to 30-year follow-up study. J Periodontol. 2019 Nov;90(11):1235-1243. doi: 10.1002/JPER.19-0032. Epub 2019 Jul 19.
PubMed 31194255Arzouman A, Deas DE, Mills MP, Huynh-Ba G, Prihoda TJ, Mealey BL. Impact of different surgical protocols on dimensional changes of free soft tissue autografts: A randomized controlled trial. J Periodontol. 2021 Jan;92(1):45-53. doi: 10.1002/JPER.20-0033. Epub 2020 Oct 16.
PubMed 32716061Cabanes-Gumbau G, Pascual-Moscardo A, Penarrocha-Oltra D, Garcia-Mira B, Aizcorbe-Vicente J, Penarrocha-Diago MA. Volumetric variation of peri-implant soft tissues in convergent collar implants and crowns using the biologically oriented preparation technique (BOPT). Med Oral Patol Oral Cir Bucal. 2019 Sep 1;24(5):e643-e651. doi: 10.4317/medoral.22946.
PubMed 31422410Cairo F, Nieri M, Cincinelli S, Mervelt J, Pagliaro U. The interproximal clinical attachment level to classify gingival recessions and predict root coverage outcomes: an explorative and reliability study. J Clin Periodontol. 2011 Jul;38(7):661-6. doi: 10.1111/j.1600-051X.2011.01732.x. Epub 2011 Apr 20.
PubMed 21507033Cevallos CAR, de Resende DRB, Damante CA, Sant'Ana ACP, de Rezende MLR, Greghi SLA, Zangrando MSR. Free gingival graft and acellular dermal matrix for gingival augmentation: a 15-year clinical study. Clin Oral Investig. 2020 Mar;24(3):1197-1203. doi: 10.1007/s00784-019-02983-0. Epub 2019 Jul 12.
PubMed 31300879De Bruyckere T, Cabeza RG, Eghbali A, Younes F, Cleymaet R, Cosyn J. A randomized controlled study comparing guided bone regeneration with connective tissue graft to reestablish buccal convexity at implant sites: A 1-year volumetric analysis. Clin Implant Dent Relat Res. 2020 Aug;22(4):468-476. doi: 10.1111/cid.12934. Epub 2020 Jul 19.
PubMed 32686234
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Evaluation of Volumetric Changes of Free Gingival Graft and Gingival Unit Graft With Indirect Method
- ClinicalTrials.gov ID
- NCT06101524
- Acronym / sponsor ID
- 2022/01-01
- Keywords
- Free gingival greft, Free gingival unit, Scanner
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Eda Cetin OzdemirUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 26 Oct 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 primary aim of this study is to evaluate the clinical results of free gingival graft and gingival unit graft by indirect method.
To evaluate the 6-month results linearly and volumetrically using an intraoral scanner (TRİOS, 3Shape, Copenhagen, Denmark) (using measurements and on a plaster model).
Detailed description
Deficiency of keratinized tissue includes mucogingival problems among different clinical entities. (Silva et al., 2010) There is no consensus on the minimum amount of attached gingiva required to maintain the health of the gums. However, there are many clinical situations that demonstrate the necessity of keratinized tissue. (Cevallos et al., 2020) (Agarwal et al., 2015) For example, if the attached gingiva is thin, it becomes difficult to perform adequate oral hygiene procedures and plaque. Inflammation and attachment loss are observed due to accumulation. (Gümüş and Buduneli, 2014) (Raoofi et al., 2019) Keratinized tissue width expresses the distance between the coronal margin of the gingival sulcus and the mucogingival line. It is considered to be the main factor in the management and protection of tissue health around natural teeth. (Agudio et al., 2019) Gingival recession refers to the apical displacement of the soft tissue margin from the cemento-enamel border. Oral hygiene and plaque with tooth sensitivity, root caries, unaesthetic appearance as well as loss of periodontal attachment causes retention. (Arzouman et al., n.d.) (Chambrone and Tatakis, 2015) In the treatment of gingival recession Many techniques have been described: Subepithelial connective tissue graft, stemmed grafts (coronally, laterally), free gingival graft (FGG), gingival unit graft (GUG). (Cevallos et al., 2020)(Sriwil et al., 2020). Although significant results are observed, there are different success rates between techniques. (Sriwil et al., 2020) FGG is used not only to cover the root surface but also to increase the width of keratinized tissue. It was first proposed by Nabers for this purpose. (Mörmann et al., 1981) Currently, the FGG's incompatible aesthetic and crude. It has many limitations due to its appearance. (Sriwil et al., 2020)
Due to the limitations of the FGG, there was a need for a new perspective on such phenomena. The vascular characteristics of the graft are important in terms of rapid capillary anastomosis with impaired vascularity of the recipient site. (Sriwil et al., 2020) Gingival sulcus, where thin blood vessels form a network and capillaries show numerous anastomoses is the place. (Jenabian et al., 2016) The vascular plexus of the gingiva, in terms of horizontal anastomoses feeding the marginal zone marginal and interdental tissues to benefit from better blood perfusion of the recipient area can be used, thus increasing the chances of survival of the graft. (Sriwil et al., 2020) (Yıldırım, 2015) The supracrestal part of the gingiva, which includes the marginal and papillary tissues, is included in the soft tissue graft taken to nourish the avascular root surface.
Studies have shown that the marginal, attached, and interdental gingival regions have significantly different vascular distributions. (Sriwil et al., 2020)
Due to these advantages of marginal and interdental tissues, the technique defined as Gingival Unit Graft (GUG) containing marginal and interdental papilla has emerged as an alternative approach to FGG. (Yıldırım, 2015) Kuru and Yıldırım, in their randomized controlled study comparing FGG and GUG in terms of keratinized tissue gain and root surface coverage, reported that DÜG gave better clinical results. (Dry oath Yıldırım, 2013)
G Power 3.1 (University Kiel, Germany) program was used to calculate the effect size. Effect size Free Gingival Graft in the study of Sriwil, Fakher (1) and an effect size of 2.12 d cohen was determined to be sufficient for significance. It was found that a total of 20 samples, at least 10 for each study group, was sufficient with a type 1 error of 0.05 and 99% power.
Free Gingival Graft was applied to 10 patients with keratinized mucosa deficiency, and Gingival Unit Graft was applied to 10 patients. Volumetric changes in the gingiva were measured both clinically and by scanner at the beginning and 6th months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free Gingival greft Group | Experimental | Procedure: Free gingival unit, free gingival greftPatients who are found to have keratinized mucosa insufficiency as a result of the examination, undergo free gingival graft to increase the keratinized mucosa. procedures will be done and you will be called for a check-up after 6 months. The keratinized tissue volume formed after the procedure will be evaluated. |
| Gingival Unit Greft Group | Experimental | Procedure: Free gingival unit, free gingival greftPatients who are found to have keratinized mucosa insufficiency as a result of the examination, undergo gingival unit graft to increase the keratinized mucosa. procedures will be done and you will be called for a check-up after 6 months. The keratinized tissue volume formed after the procedure will be evaluated. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are systemically healty,
Key exclusion criteria (1 listed)
- -
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 unit, free gingival greftThe free gingival graft and the free gingival unit taken from the upper jaw palatal mucosa were sutured to the lower jaw anterior region. | Procedure or surgery | Free Gingival greft Group, Gingival Unit Greft Group |
Primary outcome
Keratinized gingival width
Time frame: İnitial and postoperative 6 months
The change in keratinized tissue width after free gingival graft and gingival graft unit operations was evaluated.
Average gingival thickness change (mm)
Time frame: İnitial and postoperative 6 months
The change in average gingival thickness change after free gingival graft and gingival graft unit operations was evaluated.
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 26 Oct 2023.
- Background: PubMed 26681852Agarwal C, Tarun Kumar AB, Mehta DS. Comparative evaluation of free gingival graft and AlloDerm((R)) in enhancing the width of attached gingival: A clinical study. Contemp Clin Dent. 2015 Oct-Dec;6(4):483-8. doi: 10.4103/0976-237X.169838.
- Background: PubMed 31194255Agudio G, Chambrone L, Selvaggi F, Pini-Prato GP. Effect of gingival augmentation procedure (free gingival graft) on reducing the risk of non-carious cervical lesions: A 25- to 30-year follow-up study. J Periodontol. 2019 Nov;90(11):1235-1243. doi: 10.1002/JPER.19-0032. Epub 2019 Jul 19.
- Background: PubMed 32716061Arzouman A, Deas DE, Mills MP, Huynh-Ba G, Prihoda TJ, Mealey BL. Impact of different surgical protocols on dimensional changes of free soft tissue autografts: A randomized controlled trial. J Periodontol. 2021 Jan;92(1):45-53. doi: 10.1002/JPER.20-0033. Epub 2020 Oct 16.
- Background: PubMed 31422410Cabanes-Gumbau G, Pascual-Moscardo A, Penarrocha-Oltra D, Garcia-Mira B, Aizcorbe-Vicente J, Penarrocha-Diago MA. Volumetric variation of peri-implant soft tissues in convergent collar implants and crowns using the biologically oriented preparation technique (BOPT). Med Oral Patol Oral Cir Bucal. 2019 Sep 1;24(5):e643-e651. doi: 10.4317/medoral.22946.
- Background: PubMed 21507033Cairo F, Nieri M, Cincinelli S, Mervelt J, Pagliaro U. The interproximal clinical attachment level to classify gingival recessions and predict root coverage outcomes: an explorative and reliability study. J Clin Periodontol. 2011 Jul;38(7):661-6. doi: 10.1111/j.1600-051X.2011.01732.x. Epub 2011 Apr 20.
- Background: PubMed 31300879Cevallos CAR, de Resende DRB, Damante CA, Sant'Ana ACP, de Rezende MLR, Greghi SLA, Zangrando MSR. Free gingival graft and acellular dermal matrix for gingival augmentation: a 15-year clinical study. Clin Oral Investig. 2020 Mar;24(3):1197-1203. doi: 10.1007/s00784-019-02983-0. Epub 2019 Jul 12.
- Background: PubMed 32686234De Bruyckere T, Cabeza RG, Eghbali A, Younes F, Cleymaet R, Cosyn J. A randomized controlled study comparing guided bone regeneration with connective tissue graft to reestablish buccal convexity at implant sites: A 1-year volumetric analysis. Clin Implant Dent Relat Res. 2020 Aug;22(4):468-476. doi: 10.1111/cid.12934. Epub 2020 Jul 19.
- Individual participant dataSharing planned: No. We have other studies using this data
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.
Eda Çetin Özdemir study chair
Kahramanmaras Sutcu Imam University
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 unit, free gingival greft in people with Ndirectly Measuring the Difference Between the Free Gingival Graft and the Free Gingival Unit Via a Scanner, run by Eda Cetin Ozdemir at 1 site in Turkey (Türkiye).
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 1 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 26 Oct 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 Turkey (Türkiye). 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?
Keratinized gingival width (time frame: İnitial and postoperative 6 months). 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?
On the ClinicalTrials.gov record for NCT06101524, which also lists 7 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 26 Oct 2023.