Gingival RecessionNCT04109794
Comparison of Two Techniques in Gingival Recession Treatment. One-year Clinical Follow-up Study
A study testing E-CTG in people with Gingival Recession, run by Kırıkkale University.
Trial summary
42 patients were treated either with E-CTG (N=20) or SCAF (N=22). The recordings included clinician-based (recession depth, recession width, probing depth, clinical attachment level, keratinized tissue width, tissue thickness, clinical attachment gain (CAG), root coverage (RC), keratinized tissue change (KTC)) and… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- E-CTG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to May 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- single Miller I GR defects ≤3mm at upper anterior or premolar teeth
- systemically healthy
- identifiable cemento-enamel junction (CEJ)
- PD ≤3 mm
Who cannot join
- periodontal surgery experience in the past two years
- excessive contacts
- mobility
- caries
- loss of vitality
- smoking
- pregnancy
About this study
42 patients were treated either with E-CTG (N=20) or SCAF (N=22). The recordings included clinician-based (recession depth, recession width, probing depth, clinical attachment level, keratinized tissue width, tissue thickness, clinical attachment gain (CAG), root coverage (RC), keratinized tissue change (KTC)) and patient-based (wound healing index (WHI), dentine hypersensitivity (DH), tissue appearance, patient expectations and aesthetics) parameters that were taken at baseline, T1 (sixth week), T2 (sixth month) and T3 (first year).
- Conditions
- Gingival Recession
- Being tested
- E-CTG
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-CTGProcedure or surgery
Envelope connective tissue graft
| Study group | Role | What they receive |
|---|---|---|
| E-CTG | Active comparator | Envelope connective tissue graft Receives: Procedure: E-CTG |
| SCAF | Active comparator | Semilunar connective tissue graft Receives: Procedure: E-CTG |
What is being measured
The primary outcome is the main question the study is designed to answer.
recession depth
Distance between CEJ and GM
Measured: baseline
recession depth
Distance between CEJ and GM
Measured: 6 weeks
recession depth
Distance between CEJ and GM
Measured: 6 months
recession depth
Distance between CEJ and GM
Measured: 12 months
Secondary outcomes (16)
recession width
horizontal distance between two borders of recession at CEJ level
Measured: baseline
recession width
horizontal distance between two borders of recession at CEJ level
Measured: 6 weeks
recession width
horizontal distance between two borders of recession at CEJ level
Measured: 6 months
recession width
horizontal distance between two borders of recession at CEJ level
Measured: 12 months
probing depth
distance between GM and base of gingival sulcus
Measured: baseline
probing depth
distance between GM and base of gingival sulcus
Measured: 6 weeks
probing depth
distance between GM and base of gingival sulcus
Measured: 6 months
probing depth
distance between GM and base of gingival sulcus
Measured: 12 months
clinical attachment level
distance between CEJ and base of gingival sulcus
Measured: baseline
clinical attachment level
distance between CEJ and base of gingival sulcus
Measured: 6 weeks
clinical attachment level
distance between CEJ and base of gingival sulcus
Measured: 6 months
clinical attachment level
distance between CEJ and base of gingival sulcus
Measured: 12 months
keratinized tissue width
distance between GM and MGJ
Measured: baseline
keratinized tissue width
distance between GM and MGJ
Measured: 6 weeks
keratinized tissue width
distance between GM and MGJ
Measured: 6 months
keratinized tissue width
distance between GM and MGJ
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 posted30 Sep 2019
- Study startDec 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, H. Gencay Keceli, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109794
- Sponsor's protocol ID
- SerdarEvginer
- Status last verified
- Sep 2019
- First submitted
- 26 Sep 2019
- Last updated
- 30 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Evginer MS, Olgun E, Parlak HM, Dolgun AB, Keceli HG. Comparison of two techniques in gingival recession treatment: A randomized one-year clinical follow-up study. Dent Med Probl. 2022 Jan-Mar;59(1):121-130. doi: 10.17219/dmp/137621.
PubMed 35394710
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Techniques in Gingival Recession Treatment. One-year Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT04109794
- Acronym / sponsor ID
- SerdarEvginer
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- Dec 2012 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 30 Sep 2019 (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.
42 patients were treated either with E-CTG (N=20) or SCAF (N=22). The recordings included clinician-based (recession depth, recession width, probing depth, clinical attachment level, keratinized tissue width, tissue thickness, clinical attachment gain (CAG), root coverage (RC), keratinized tissue change (KTC)) and patient-based (wound healing index (WHI), dentine hypersensitivity (DH), tissue appearance, patient expectations and aesthetics) parameters that were taken at baseline, T1 (sixth week), T2 (sixth month) and T3 (first year).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-CTG | Active comparator | Procedure: E-CTGEnvelope connective tissue graft |
| SCAF | Active comparator | Procedure: E-CTGSemilunar connective tissue graft |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- single Miller I GR defects ≤3mm at upper anterior or premolar teeth
- systemically healthy
- identifiable cemento-enamel junction (CEJ)
- PD ≤3 mm
Key exclusion criteria (7 listed)
- periodontal surgery experience in the past two years
- excessive contacts
- mobility
- caries
- loss of vitality
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 |
|---|---|---|
| E-CTGEnvelope connective tissue graft | Procedure or surgery | E-CTG, SCAF |
Primary outcome
recession depth
Time frame: baseline
Distance between CEJ and GM
recession depth
Time frame: 6 weeks
Distance between CEJ and GM
recession depth
Time frame: 6 months
Distance between CEJ and GM
recession depth
Time frame: 12 months
Distance between CEJ and GM
16 secondary outcomes
recession width
Time frame: baseline
recession width
Time frame: 6 weeks
recession width
Time frame: 6 months
recession width
Time frame: 12 months
probing depth
Time frame: baseline
probing depth
Time frame: 6 weeks
probing depth
Time frame: 6 months
probing depth
Time frame: 12 months
clinical attachment level
Time frame: baseline
clinical attachment level
Time frame: 6 weeks
clinical attachment level
Time frame: 6 months
clinical attachment level
Time frame: 12 months
keratinized tissue width
Time frame: baseline
keratinized tissue width
Time frame: 6 weeks
keratinized tissue width
Time frame: 6 months
keratinized tissue width
Time frame: 12 months
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 30 Sep 2019.
- Derived from this study: PubMed 35394710Evginer MS, Olgun E, Parlak HM, Dolgun AB, Keceli HG. Comparison of two techniques in gingival recession treatment: A randomized one-year clinical follow-up study. Dent Med Probl. 2022 Jan-Mar;59(1):121-130. doi: 10.17219/dmp/137621.
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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 E-CTG in people with Gingival Recession, run by Kırıkkale University.
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 7 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 30 Sep 2019. 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?
recession depth (time frame: baseline). 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?
On the ClinicalTrials.gov record for NCT04109794, which also lists 1 linked publication.
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 30 Sep 2019.