Gingival RecessionNCT03295604
A Novel Volumetric Analysis Using CAD/CAM Scanners in Gingival Recession Treatment
A study testing SCTG+EMD and SCTG in people with Gingival Recession, run by Hacer Sahin Aydinyurt.
Trial summary
Aim: In this ramdomised clinical trial (RCT), the aim was to compare clinical periodontal data of subepithelial connective tissue graft (SCTG) group and SCGT+enamel matrix derivatives (EMD) group in terms of gained gingiva volume (GGV) and gained gingiva surface area (GGSA) by scanners of computer-aided… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- SCTG+EMD and SCTG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Dec 2014
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- individuals should have no systemic disease
- non-smokers of cigarette or tobacco products
- not in a pregnancy,
- have not used any antibiotics or medications with an impact on the immune system within last 6 months,
- have GR classified as Miller class I or class II
- have GR depth of ≥2mm ,
- have no decay or restoration on the vital teeth which will be operated
- have no operation history with regard to GRs for related tooth area.
Who cannot join
- pregnancy
- smoking
- Miller class III and IV gingival recession
- antibiotic use
About this study
Official title: A Novel Volumetric Analysis Using CAD/CAM Scanners in Gingival Recession
Aim: In this ramdomised clinical trial (RCT), the aim was to compare clinical periodontal data of subepithelial connective tissue graft (SCTG) group and SCGT+enamel matrix derivatives (EMD) group in terms of gained gingiva volume (GGV) and gained gingiva surface area (GGSA) by scanners of computer-aided design/computer-aided manufacturing (CAD/CAM) devices.
Materials and Methods: A total of 35 Miller class I-II gingival recession defects were involved in this study (n=17 in SCTG group, n=18 in SCTG+EMD group). In addition to periodontal clinical parameters, three dimensional (3D) images were recorded using CAD/CAM system before the treatment, at the 1st month and at the 6th months after the treatment. The images were superimposed using softwares and GGV, GGSA were calculated.
Read the detailed description
Study populations:
In this study, totally 35 gingival recession (GR) defects in 35 patients, who applied with complaints of poor aesthetic and/or root surface sensitivity. Following patients were admitted to the study: individuals should have no systemic disease, should be non-smokers of cigarette or tobacco products, not in a pregnancy, have not used any antibiotics or medications with an impact on the immune system within last 6 months, have GR classified as Miller class I or class II, have GR depth of ≥2mm , have no decay or restoration on the vital teeth which will be operated, have no operation history with regard to GRs for related tooth area. The materials and methods of this study were approved by the Non-Drug Clinical Researches Ethics Committee of Yüzüncü Yıl University (B.30.2.YYU.0.01.00.00/32).
Study Groups:
In SCTG group 17 of GRs defects and in SCTG+EMD group 18 GRs defects were treated. While GRs in SCTG group was treated by SCTG and CPF combination therapy, EMD (Emdogain, Straumann, Basel, Switzerland) was additionally used in GR treatments of SCTG+EMD group. Patients were randomized by complete randomization method (SPSS 15; SPSS Inc., Chicago, IL, USA) to assign them into groups.
Pre-surgical Procedure:
Patients were informed about the potential causes of GRs. Causative habits of GR have been eliminated. Baseline periodontal treatments of the patients were performed. Plaque index (PI) , gingival index (GI) , probing pocket depth (PPD) (mm), clinical attachment level (CAL) (mm) were recorded before periodontal treatment. We prepared patients with total PI scores less than 15% for the surgical procedure (O'Leary et al 1972). Pre-treatment 3D soft tissue images were taken by CEREC Omnicam (Sirona Dental Systems GmbH, Bensheim, Germany) from intra-oral region. Recipient zone was prepared using the Langer method. SCTG was extracted ipsilaterally with the operation site from the palatal region between distal of canine and mesial of 1st molar tooth. Incision was performed in parallel with free gingival margin using Harris graft knife (Harris Double Blade Graft Knife, H \& H Company, Ontario, CA, USA). Harvested graft was implanted to recipient zone so that its periosteal side faces with root surface and overhangs defect borders by 1mm. In order to remove the smear layer on the root surface of the teeth in SCTG+EMD group, 24% EDTA (Prefgel, Straumann, Basel, Switzerland) was applied for two minutes onto the root surface and operation site was washed with normal saline in order to remove any residual EDTA. EMD was applied to entire root surface compatible with manufacturer's instructions .
Post-surgical Procedure:
3D images and clinical parameter values were recorded during follow-up examinations at the 1st and the 6th month after the periodontal surgery. 3D images of soft tissue were taken intraorally with CEREC Omnicam® device at the commencement of treatment as well as at the post-operative 1st and 6th months . The measurements were recorded as in rst.img format which is a file extension of CEREC system®. The operation site was cut out from the image which was recorded at the 1st and at the 6th month. Images of each patient which were taken in three different time points were overlapped on Mimics 10 software. GGV and GGSA measurements were made on the overlapped images. the GGV and GGSA were calculated the difference in tissue as obtained after overlapping the 3D images by the software. Changes at the 1st and the 6th month after treatment were calculated with respect to pre-treatment images .
- Conditions
- Gingival Recession
- Being tested
- SCTG+EMD, SCTG
- Keywords
- Gingival recession, Subepithelial connective tissue grafts, CAD/CAM
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCTG+EMDProcedure or surgery
Miller class I-II gingival recession defects were operated with SCTG+EMD
SCTGProcedure or surgery
Miller class I-II gingival recession defects were operated with SCTG only and
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | Miller class I-II gingival recession defects operated with sub epithelial connective tissue graft (SCTG) in addition with enamel matrix derivatives (EMD) (Emdogain ®, Switzerland ) in SCTG+EMD group. Receives: Procedure: SCTG+EMD |
| control group | Experimental | Miller class I-II gingival recession defects operated with only sub epithelial connective tissue graft (SCTG). No drug or something else were used Receives: Procedure: SCTG |
What is being measured
The primary outcome is the main question the study is designed to answer.
GGV
Gingival gain volume: measured by software on images (mm3)
Measured: 6 months
GGSA
Gingival gain of surface area: measured by software on images (mm2
Measured: 6 months
GRH
gingival recession height: the distance between cementoenamel junction to gingival margin (mm)
Measured: 6 months
GRW
gingival recession width: the distance between mesial and distal gingival margins (mm)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study startApr 2014
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacer Sahin Aydinyurt
- Sponsor type
- University, hospital or other
- Collaborators
- Yuzuncu Yil University
- Responsible party
- Sponsor-investigator, Hacer Sahin Aydinyurt, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295604
- Sponsor's protocol ID
- YuzuncuYıl 3
- Status last verified
- Sep 2017
- First submitted
- 16 Aug 2017
- Last updated
- 28 Sep 2017
- 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 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Volumetric Analysis Using CAD/CAM Scanners in Gingival Recession
- ClinicalTrials.gov ID
- NCT03295604
- Acronym / sponsor ID
- YuzuncuYıl 3
- Conditions
- Gingival Recession
- Keywords
- Gingival recession, Subepithelial connective tissue grafts, CAD/CAM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hacer Sahin AydinyurtUniversity, hospital or other
- Collaborators
- Yuzuncu Yil University
- Study start
- Apr 2014 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Sep 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.
Aim: In this ramdomised clinical trial (RCT), the aim was to compare clinical periodontal data of subepithelial connective tissue graft (SCTG) group and SCGT+enamel matrix derivatives (EMD) group in terms of gained gingiva volume (GGV) and gained gingiva surface area (GGSA) by scanners of computer-aided design/computer-aided manufacturing (CAD/CAM) devices.
Materials and Methods: A total of 35 Miller class I-II gingival recession defects were involved in this study (n=17 in SCTG group, n=18 in SCTG+EMD group). In addition to periodontal clinical parameters, three dimensional (3D) images were recorded using CAD/CAM system before the treatment, at the 1st month and at the 6th months after the treatment. The images were superimposed using softwares and GGV, GGSA were calculated.
Detailed description
Study populations:
In this study, totally 35 gingival recession (GR) defects in 35 patients, who applied with complaints of poor aesthetic and/or root surface sensitivity. Following patients were admitted to the study: individuals should have no systemic disease, should be non-smokers of cigarette or tobacco products, not in a pregnancy, have not used any antibiotics or medications with an impact on the immune system within last 6 months, have GR classified as Miller class I or class II, have GR depth of ≥2mm , have no decay or restoration on the vital teeth which will be operated, have no operation history with regard to GRs for related tooth area. The materials and methods of this study were approved by the Non-Drug Clinical Researches Ethics Committee of Yüzüncü Yıl University (B.30.2.YYU.0.01.00.00/32).
Study Groups:
In SCTG group 17 of GRs defects and in SCTG+EMD group 18 GRs defects were treated. While GRs in SCTG group was treated by SCTG and CPF combination therapy, EMD (Emdogain, Straumann, Basel, Switzerland) was additionally used in GR treatments of SCTG+EMD group. Patients were randomized by complete randomization method (SPSS 15; SPSS Inc., Chicago, IL, USA) to assign them into groups.
Pre-surgical Procedure:
Patients were informed about the potential causes of GRs. Causative habits of GR have been eliminated. Baseline periodontal treatments of the patients were performed. Plaque index (PI) , gingival index (GI) , probing pocket depth (PPD) (mm), clinical attachment level (CAL) (mm) were recorded before periodontal treatment. We prepared patients with total PI scores less than 15% for the surgical procedure (O'Leary et al 1972). Pre-treatment 3D soft tissue images were taken by CEREC Omnicam (Sirona Dental Systems GmbH, Bensheim, Germany) from intra-oral region. Recipient zone was prepared using the Langer method. SCTG was extracted ipsilaterally with the operation site from the palatal region between distal of canine and mesial of 1st molar tooth. Incision was performed in parallel with free gingival margin using Harris graft knife (Harris Double Blade Graft Knife, H \& H Company, Ontario, CA, USA). Harvested graft was implanted to recipient zone so that its periosteal side faces with root surface and overhangs defect borders by 1mm. In order to remove the smear layer on the root surface of the teeth in SCTG+EMD group, 24% EDTA (Prefgel, Straumann, Basel, Switzerland) was applied for two minutes onto the root surface and operation site was washed with normal saline in order to remove any residual EDTA. EMD was applied to entire root surface compatible with manufacturer's instructions .
Post-surgical Procedure:
3D images and clinical parameter values were recorded during follow-up examinations at the 1st and the 6th month after the periodontal surgery. 3D images of soft tissue were taken intraorally with CEREC Omnicam® device at the commencement of treatment as well as at the post-operative 1st and 6th months . The measurements were recorded as in rst.img format which is a file extension of CEREC system®. The operation site was cut out from the image which was recorded at the 1st and at the 6th month. Images of each patient which were taken in three different time points were overlapped on Mimics 10 software. GGV and GGSA measurements were made on the overlapped images. the GGV and GGSA were calculated the difference in tissue as obtained after overlapping the 3D images by the software. Changes at the 1st and the 6th month after treatment were calculated with respect to pre-treatment images .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Procedure: SCTG+EMDMiller class I-II gingival recession defects operated with sub epithelial connective tissue graft (SCTG) in addition with enamel matrix derivatives (EMD) (Emdogain ®, Switzerland ) in SCTG+EMD group. |
| control group | Experimental | Procedure: SCTGMiller class I-II gingival recession defects operated with only sub epithelial connective tissue graft (SCTG). No drug or something else were used |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- individuals should have no systemic disease
- non-smokers of cigarette or tobacco products
- not in a pregnancy,
- have not used any antibiotics or medications with an impact on the immune system within last 6 months,
- have GR classified as Miller class I or class II
Key exclusion criteria (4 listed)
- pregnancy
- smoking
- Miller class III and IV gingival recession
- antibiotic use
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 |
|---|---|---|
| SCTG+EMDMiller class I-II gingival recession defects were operated with SCTG+EMD | Procedure or surgery | test group |
| SCTGMiller class I-II gingival recession defects were operated with SCTG only and | Procedure or surgery | control group |
Primary outcome
GGV
Time frame: 6 months
Gingival gain volume: measured by software on images (mm3)
GGSA
Time frame: 6 months
Gingival gain of surface area: measured by software on images (mm2
GRH
Time frame: 6 months
gingival recession height: the distance between cementoenamel junction to gingival margin (mm)
GRW
Time frame: 6 months
gingival recession width: the distance between mesial and distal gingival margins (mm)
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 28 Sep 2017.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing SCTG+EMD and SCTG in people with Gingival Recession, run by Hacer Sahin Aydinyurt.
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 8 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 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
GGV (time frame: 6 months). The study lists 4 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 28 Sep 2017; AzTrials last refreshed its copy on 31 Oct 2026.