Clinical TrialNCT04611282
Surgical Treatment of Gingival Recessions
A study testing surgical techniques in the treatment of localized gingival recession defects. in people with Clinical Trial and Connective Tissue, run by Istanbul Medipol University Hospital.
Trial summary
The purpose of this study was to compare the effectiveness of microsurgical and macrosurgical approaches on CPFs plus SCTGs for the treatment of localized gingival recession defects (Miller class I or II) over the course of 6 months based on clinical periodontal parameters, periodontal phenotypes, and the… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Trial, Connective Tissue, Gingival Recession
- What is being tested?
- surgical techniques in the treatment of localized gingival recession defects.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
- All participants were:
- adults aged 18 years or over
- systemically and periodontally healthy
- met the eligibility criteria for localized gingival recession of the canine or premolar teeth according to the Miller classification scheme
Who cannot join
- -
- medical disorders such as diabetes mellitus, immunologic disorders, and hepatitis;
- a history of chemotherapy or radiotherapy;
- a history of alcoholism or drug abuse;
- a history of previous mucogingival surgery at the gingival recession site;
- medications known to affect gingival tissues;
Show all 9Show fewer
- antibiotic treatment in the past 6 months;
- smoking >10 cigarettes per day for >5 years, and;
- current pregnancy or lactation.
About this study
Official title: Micro and Macrosurgical Treatment of Gingival Recessions: a Randomized Clinical Trial
The purpose of this study was to compare the effectiveness of microsurgical and macrosurgical approaches on CPFs plus SCTGs for the treatment of localized gingival recession defects (Miller class I or II) over the course of 6 months based on clinical periodontal parameters, periodontal phenotypes, and the postoperative complaints and satisfaction levels of the patients. We hypothesized that root coverage achieved through microsurgery in Miller I or II gingival recessions would improve clinical periodontal outcomes and the periodontal phenotype, with greater postoperative comfort and aesthetic satisfaction in comparison with conventional macrosurgical techniques. Miller Class I and II gingival recession defects, at least 3.0 mm deep, were selected and randomly assigned to receive micro or macrosurgical techniques. Both techniques were performed using a coronally positioned flap with a subepithelial connective tissue graft. Plaque and gingival indices, gingival recession depth and width, probing pocket depth, bleeding on probing, clinical attachment level, width of keratinized gingiva, aesthetic score and percentage of root coverage, postoperative complaints, and satisfaction of the participants completing the study were evaluated at follow-up 1st, 3rd and 6th months.
- Conditions
- Clinical Trial, Connective Tissue, Gingival Recession, Microsurgery
- Being tested
- surgical techniques in the treatment of localized gingival recession defects.
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical techniques in the treatment of localized gingival recession defects.Procedure or surgery
Micro or macrosurgical echniques were performed using a coronally positioned flap with a subepithelial connective tissue graft.
| Study group | Role | What they receive |
|---|---|---|
| Microsurgery group | Experimental | All defects were treated with a CPF plus an SCTG by the same investigator using microsurgery technique. Receives: Procedure: surgical techniques in the treatment of localized gingival recession defects. |
| Macrosurgery group | Active comparator | All defects were treated with a CPF plus an SCTG by the same investigator using macrosurgery technique. Receives: Procedure: surgical techniques in the treatment of localized gingival recession defects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of root coverage
The primary endpoint for efficacy of the gingival recession was the percentage of root coverage at baseline and 6-months postsurgery, as measured by gingival recession depth.
Measured: 6 months
Secondary outcomes (4)
Changes in Gingival recession depth
Measured: 6 months
Changes in Gingival recession width
Measured: 6 months
Changes in Keratinized gingival width
Measured: 6 months
visual analog scale
A visual analog scale was used to evaluate postoperative complaints regarding the recipient and donor sites according to graft size and postoperative satisfaction values (level of the gingival margin, gingival tissue color, dentin hypersensitivity, and root coverage) during the follow-up period. A 10 cm VAS, with "none" / "unhappy" at the left end and "unbearable" / "happy" at the right end was prepared for each patient.
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 posted2 Nov 2020
- Study startDec 2016
- Primary completionMay 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical TrialStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kocaeli University
- Responsible party
- Principal investigator, Begum Alkan, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611282
- Sponsor's protocol ID
- Mamtograrct
- Status last verified
- Sep 2023
- First submitted
- 12 Oct 2020
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro and Macrosurgical Treatment of Gingival Recessions: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04611282
- Acronym / sponsor ID
- Mamtograrct
- Conditions
- Clinical Trial, Connective Tissue, Gingival Recession, Microsurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Kocaeli University
- Study start
- Dec 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 2 Nov 2020 (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 purpose of this study was to compare the effectiveness of microsurgical and macrosurgical approaches on CPFs plus SCTGs for the treatment of localized gingival recession defects (Miller class I or II) over the course of 6 months based on clinical periodontal parameters, periodontal phenotypes, and the postoperative complaints and satisfaction levels of the patients. We hypothesized that root coverage achieved through microsurgery in Miller I or II gingival recessions would improve clinical periodontal outcomes and the periodontal phenotype, with greater postoperative comfort and aesthetic satisfaction in comparison with conventional macrosurgical techniques. Miller Class I and II gingival recession defects, at least 3.0 mm deep, were selected and randomly assigned to receive micro or macrosurgical techniques. Both techniques were performed using a coronally positioned flap with a subepithelial connective tissue graft. Plaque and gingival indices, gingival recession depth and width, probing pocket depth, bleeding on probing, clinical attachment level, width of keratinized gingiva, aesthetic score and percentage of root coverage, postoperative complaints, and satisfaction of the participants completing the study were evaluated at follow-up 1st, 3rd and 6th months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microsurgery group | Experimental | Procedure: surgical techniques in the treatment of localized gingival recession defects.All defects were treated with a CPF plus an SCTG by the same investigator using microsurgery technique. |
| Macrosurgery group | Active comparator | Procedure: surgical techniques in the treatment of localized gingival recession defects.All defects were treated with a CPF plus an SCTG by the same investigator using macrosurgery technique. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- -
- adults aged 18 years or over
- systemically and periodontally healthy
- met the eligibility criteria for localized gingival recession of the canine or premolar teeth according to the Miller classification scheme
Key exclusion criteria (9 listed)
- -
- medical disorders such as diabetes mellitus, immunologic disorders, and hepatitis;
- a history of chemotherapy or radiotherapy;
- a history of alcoholism or drug abuse;
- a history of previous mucogingival surgery at the gingival recession site;
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 |
|---|---|---|
| surgical techniques in the treatment of localized gingival recession defects.Micro or macrosurgical echniques were performed using a coronally positioned flap with a subepithelial connective tissue graft. | Procedure or surgery | Macrosurgery group, Microsurgery group |
Primary outcome
Percentage of root coverage
Time frame: 6 months
The primary endpoint for efficacy of the gingival recession was the percentage of root coverage at baseline and 6-months postsurgery, as measured by gingival recession depth.
4 secondary outcomes
Changes in Gingival recession depth
Time frame: 6 months
Changes in Gingival recession width
Time frame: 6 months
Changes in Keratinized gingival width
Time frame: 6 months
visual analog scale
Time frame: 6 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 28 Sep 2023.
- Individual participant dataSharing planned: No
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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 surgical techniques in the treatment of localized gingival recession defects. in people with Clinical Trial and Connective Tissue, run by Istanbul Medipol University Hospital.
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: finished, as of the sponsor's last update on 28 Sep 2023. 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?
Percentage of root coverage (time frame: 6 months). 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 2023.