Gingival Recession, Mucogingival SurgeryNCT02281071
Microsurgical Instruments and Magnification May Enhance Treatment Outcomes Of Laterally Moved, Coronally Advanced Flap in Miller Class III Isolated Recession Defects
A study testing laterally moved coronally advanced flap with microsurgical instruments and x2.5 loupe in people with Gingival Recession, Mucogingival Surgery, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The benefits of microsurgical approaches in periodontal therapy have been described. The main focus of this study is to determine if using microsurgical LMCAF technique would improve the outcomes of the therapy for the Miller Class III isolated recession-type defects. Read more about this study
- Who is it for?
- Ages 22 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Mucogingival Surgery
- What is being tested?
- laterally moved coronally advanced flap with microsurgical instruments and x2.5 loupe
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2012to Oct 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 22 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Presence of Miller Class III isolated gingival recessions located at upper and lower incisors and canines (Miller 1985)
- Presence of identifiable cementoenamel junction (CEJ)
- Presence of a step ≤ 2mm at CEJ level and/or the presence of a root abrasion, but with an identifiable CEJ
- Lateral keratinized tissue width at least 6 mm greater than the width of the recession measured at the level of the cemento-enamel junction (CEJ)
- Lateral keratinized tissue height at least 2 mm greater than the buccal probing depth of the adjacent tooth/teeth
- Full-mouth plaque score and full-mouth bleeding score of < 15% (four sites/tooth) -No occlusal interferences; all patients were nonsmokers
Who cannot join
- Tooth with a prosthetic crown or restoration involving CEJ
- Patients with a history of destructive periodontal disease (o zaman class 3 nasıl oluştu demiş adam) or repeated abscess formation
- Presence of systemic disease or taking medications known to interfere with periodontal tissue health or healing (patients with insulin-dependent diabetes
- History of malignancy, radiotherapy, or chemotherapy for malignancy
- Disease affecting connective tissue metabolism)
- Patient pregnant or nursing during the past 5 months
- Patients who participated in a clinical trial within the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
The benefits of microsurgical approaches in periodontal therapy have been described. The main focus of this study is to determine if using microsurgical LMCAF technique would improve the outcomes of the therapy for the Miller Class III isolated recession-type defects.
Six months results of this study showed that LMCAF with microsurgical approach offered better complete and mean root coverage results over macrosurgical LMCAF technique. The superior effect of microsurgical approach on post-operative morbidity can make this technique more preferable for the patients who expected comfortable postoperative period.
This study supports that using the microsurgical aproach with LMCAF procedure significantly affects the clinical and patient-centered success of treating Miller Class III isolated typed defects.
- Conditions
- Gingival Recession, Mucogingival Surgery
- Being tested
- laterally moved coronally advanced flap with microsurgical instruments and x2.5 loupe
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laterally moved coronally advanced flap with microsurgical instruments and x2.5 loupeProcedure or surgery
The recipient area for the laterally moved flap was prepared. When the flap was moved in the distal-mesial direction another short horizontal incision was performed at the most apical extension of this vertical incision. Once the mucogingival line was reached, flap elevation was continued split-thickness. Flap elevation was terminated when it was possible to passively move the flap laterally above the exposed root. Flap was sutured.
| Study group | Role | What they receive |
|---|---|---|
| laterally moved coronally advanced flap microsurgical | Experimental | For the test group (LMCAF-M), the surgical procedures were performed with the aid of a galilean loupe, under 2.5x magnification vision, microsurgical instruments and microsurgical suture material . Receives: Procedure: laterally moved coronally advanced flap with microsurgical instruments and x2.5 loupe |
| laterally moved coronally advanced flap macrosurgical | Active comparator | For the control group (LMCAF), LMCAF was performed with conventional instruments (detaylı) and materials (stur). Loupe magnification, microsurgical instruments and suture material were not used in the control group. Receives: Procedure: laterally moved coronally advanced flap with microsurgical instruments and x2.5 loupe |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of root coverage
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study startJan 2012
- Primary completionMar 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival Recession, Mucogingival SurgeryStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Ozcelik, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281071
- Sponsor's protocol ID
- CukurovaU2
- Status last verified
- Oct 2014
- First submitted
- 30 Oct 2014
- Last updated
- 3 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microsurgical Instruments and Magnification May Enhance Treatment Outcomes Of Laterally Moved, Coronally Advanced Flap in Miller Class III Isolated Recession Defects
- ClinicalTrials.gov ID
- NCT02281071
- Acronym / sponsor ID
- CukurovaU2
- Conditions
- Gingival Recession, Mucogingival Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 3 Nov 2014 (estimated)
- 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 benefits of microsurgical approaches in periodontal therapy have been described. The main focus of this study is to determine if using microsurgical LMCAF technique would improve the outcomes of the therapy for the Miller Class III isolated recession-type defects.
Six months results of this study showed that LMCAF with microsurgical approach offered better complete and mean root coverage results over macrosurgical LMCAF technique. The superior effect of microsurgical approach on post-operative morbidity can make this technique more preferable for the patients who expected comfortable postoperative period.
This study supports that using the microsurgical aproach with LMCAF procedure significantly affects the clinical and patient-centered success of treating Miller Class III isolated typed defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laterally moved coronally advanced flap microsurgical | Experimental | Procedure: laterally moved coronally advanced flap with microsurgical instruments and x2.5 loupeFor the test group (LMCAF-M), the surgical procedures were performed with the aid of a galilean loupe, under 2.5x magnification vision, microsurgical instruments and microsurgical suture material . |
| laterally moved coronally advanced flap macrosurgical | Active comparator | Procedure: laterally moved coronally advanced flap with microsurgical instruments and x2.5 loupeFor the control group (LMCAF), LMCAF was performed with conventional instruments (detaylı) and materials (stur). Loupe magnification, microsurgical instruments and suture material were not used in the control group. |
Who may qualify
- Ages
- 22 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Presence of Miller Class III isolated gingival recessions located at upper and lower incisors and canines (Miller 1985)
- Presence of identifiable cementoenamel junction (CEJ)
- Presence of a step ≤ 2mm at CEJ level and/or the presence of a root abrasion, but with an identifiable CEJ
- Lateral keratinized tissue width at least 6 mm greater than the width of the recession measured at the level of the cemento-enamel junction (CEJ)
- Lateral keratinized tissue height at least 2 mm greater than the buccal probing depth of the adjacent tooth/teeth
Key exclusion criteria (7 listed)
- Tooth with a prosthetic crown or restoration involving CEJ
- Patients with a history of destructive periodontal disease (o zaman class 3 nasıl oluştu demiş adam) or repeated abscess formation
- Presence of systemic disease or taking medications known to interfere with periodontal tissue health or healing (patients with insulin-dependent diabetes
- History of malignancy, radiotherapy, or chemotherapy for malignancy
- Disease affecting connective tissue metabolism)
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 |
|---|---|---|
| laterally moved coronally advanced flap with microsurgical instruments and x2.5 loupeThe recipient area for the laterally moved flap was prepared. When the flap was moved in the distal-mesial direction another short horizontal incision was performed at the most apical extension of this vertical incision. Once the mucogingival line was reached, flap elevation was continued split-thickness. Flap elevation was terminated when it was possible to passively move the flap laterally above the exposed root. Flap was sutured. | Procedure or surgery | laterally moved coronally advanced flap macrosurgical, laterally moved coronally advanced flap microsurgical |
Primary outcome
the percentage of root coverage
Time frame: at 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 3 Nov 2014.
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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 laterally moved coronally advanced flap with microsurgical instruments and x2.5 loupe in people with Gingival Recession, Mucogingival Surgery, run by Cukurova University 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 6 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 3 Nov 2014. 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?
the percentage of root coverage (time frame: at 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 3 Nov 2014.