Gingival RecessionNCT02441127
Diode Laser for Harvesting Gingival Graft
A study testing diode laser group in people with Gingival Recession, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
Aims: The aim of present randomized controlled clinical study was to evaluate whether the additional use of diode laser would facilitate the donor surgery, improve the palatal wound healing and reduce post-operative morbidity after the coronally advanced flap (CAF) with connective tissue (CTG) grafts. Read more about this study
- Who is it for?
- Ages 21 to 38 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- diode laser group
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2012to Nov 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 21 to 38 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of identifiable buccal cemento-enamel junction;
- Presence of a step ≤ 1mm at the cemento-enamel junction level
- No contraindications for periodontal surgery and no periodontal surgery on the involved sites
- Full-mouth plaque score of <10%; full-mouth bleeding score of <15%
- No occlusal interferences.
Who cannot join
- History of periodontitis or abscess formation
- Presence of systemic disease
- Smokers
- Pregnant patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diode Laser For Harvesting Subepithelial Connective Tissue Graft in The Treatment of Gingival Recession Defects: A Novel Approach to Limit Morbidity
Aims: The aim of present randomized controlled clinical study was to evaluate whether the additional use of diode laser would facilitate the donor surgery, improve the palatal wound healing and reduce post-operative morbidity after the coronally advanced flap (CAF) with connective tissue (CTG) grafts.
Methods: Fifty-two patients with isolated recessions were treated. The CTG resulted from the de-epithelialization of a free gingival graft (FGG) with blade (control group) or diode laser (DL) (test group). The DL was used to de-epithelialize the outer part of the FGG and photo-biostimulate the palatal wound area. Post-operative morbidity was evaluated by using Oral health related Quality of life (QoL), smile related QoL and visual analogue scale-discomfort (VAS). Root coverage outcomes were also evaluated 6 months after operation.
Read the detailed description
The procedure of connective tissue harvesting from the palate is often characterized by the challenge of obtaining the largest volume of tissue possible on one side while minimizing post-operative pain and reducing the risk of complications on the other.The present clinical study evaluated whether the additional use of diode laser would facilitate the donor surgery, improve the palatal wound healing and reduce post-operative morbidity after the bilaminar periodontal plastic surgery procedure for the treatment of isolated single gingival recession defects with no loss of interdental clinical attachment.
In the test sites, an aluminum, gallium, and arsenide diode laser (wavelength 810 nm and power of 1W) was applied in continuous mode. In the control group,a free (epithelialized) gingival graft was harvested by two horizontal and two vertical incisions defining the area. The post operative course of the patients were evaluated by visual analogical scale and the oral health impact profile
- Conditions
- Gingival Recession
- Being tested
- diode laser group, scalpel control group
- Keywords
- free gingival graft, diode laser, donor site, mucogingival surgery
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diode laser groupDevice
the laser tip was used to remove all visible epithelium in the outer side of the defined graft area. The treatment was performed from the coronal to the apical aspect in parallel paths, and care was taken to avoid any laser contact to the palatal bone and periosteum by aiming the laser beam at a 450 angle to the palatal soft-tissue. The resultant layer on the surface was totally removed with knife and moist gauze. Then, the graft was harvested from the de-epithelized area with a 15c blade.
scalpel control groupProcedure or surgery
In the control group tissue was obtained by two horizontal and two vertical incisions defining the area to be harvested. The blade was oriented perpendicular to the bone along the coronal horizontal incision and once an adequate soft tissue thickness was obtained; it was rotated in order to be parallel to the superficial surface. The thickness of the graft was maintained uniform while proceeding apically with the blade until the FGG was harvested. The palatal wound was protected with equine-derived collagen maintained by compressive sling 5-0 sutures
| Study group | Role | What they receive |
|---|---|---|
| Diode laser group | Experimental | In the test sites, an aluminum, gallium, and arsenide diode laser (wavelength 810 nm and power of 1W) was applied in continuous mode. Receives: Device: diode laser group |
| Scalpel control group | Active comparator | The surgical technique used in the control group was a FGG harvested by two horizontal and two vertical incisions by scalpel defining the area to be harvested . Receives: Procedure: scalpel control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral health related quality of life
Measured: 6 months
Secondary outcomes (3)
Complete root coverage
Measured: 6 months
Smile related quality of life
Measured: 6 months
Post-operative Discomfort on the Visual Analog scale
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startOct 2012
- Primary completionApr 2014
- Study completionNov 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Ozcelik, Cukurova University
- Investigators
- Onur Ozcelik, PhD, Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441127
- Sponsor's protocol ID
- CukurovaU4
- Status last verified
- May 2015
- First submitted
- 29 Apr 2015
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diode Laser For Harvesting Subepithelial Connective Tissue Graft in The Treatment of Gingival Recession Defects: A Novel Approach to Limit Morbidity
- ClinicalTrials.gov ID
- NCT02441127
- Acronym / sponsor ID
- CukurovaU4
- Conditions
- Gingival Recession
- Keywords
- free gingival graft, diode laser, donor site, mucogingival surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 12 May 2015 (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.
Aims: The aim of present randomized controlled clinical study was to evaluate whether the additional use of diode laser would facilitate the donor surgery, improve the palatal wound healing and reduce post-operative morbidity after the coronally advanced flap (CAF) with connective tissue (CTG) grafts.
Methods: Fifty-two patients with isolated recessions were treated. The CTG resulted from the de-epithelialization of a free gingival graft (FGG) with blade (control group) or diode laser (DL) (test group). The DL was used to de-epithelialize the outer part of the FGG and photo-biostimulate the palatal wound area. Post-operative morbidity was evaluated by using Oral health related Quality of life (QoL), smile related QoL and visual analogue scale-discomfort (VAS). Root coverage outcomes were also evaluated 6 months after operation.
Detailed description
The procedure of connective tissue harvesting from the palate is often characterized by the challenge of obtaining the largest volume of tissue possible on one side while minimizing post-operative pain and reducing the risk of complications on the other.The present clinical study evaluated whether the additional use of diode laser would facilitate the donor surgery, improve the palatal wound healing and reduce post-operative morbidity after the bilaminar periodontal plastic surgery procedure for the treatment of isolated single gingival recession defects with no loss of interdental clinical attachment.
In the test sites, an aluminum, gallium, and arsenide diode laser (wavelength 810 nm and power of 1W) was applied in continuous mode. In the control group,a free (epithelialized) gingival graft was harvested by two horizontal and two vertical incisions defining the area. The post operative course of the patients were evaluated by visual analogical scale and the oral health impact profile
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diode laser group | Experimental | Device: diode laser groupIn the test sites, an aluminum, gallium, and arsenide diode laser (wavelength 810 nm and power of 1W) was applied in continuous mode. |
| Scalpel control group | Active comparator | Procedure: scalpel control groupThe surgical technique used in the control group was a FGG harvested by two horizontal and two vertical incisions by scalpel defining the area to be harvested . |
Who may qualify
- Ages
- 21 to 38 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Presence of identifiable buccal cemento-enamel junction;
- Presence of a step ≤ 1mm at the cemento-enamel junction level
- No contraindications for periodontal surgery and no periodontal surgery on the involved sites
- Full-mouth plaque score of <10%; full-mouth bleeding score of <15%
- No occlusal interferences.
Key exclusion criteria (4 listed)
- History of periodontitis or abscess formation
- Presence of systemic disease
- Smokers
- Pregnant patients.
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 |
|---|---|---|
| diode laser groupthe laser tip was used to remove all visible epithelium in the outer side of the defined graft area. The treatment was performed from the coronal to the apical aspect in parallel paths, and care was taken to avoid any laser contact to the palatal bone and periosteum by aiming the laser beam at a 450 angle to the palatal soft-tissue. The resultant layer on the surface was totally removed with knife and moist gauze. Then, the graft was harvested from the de-epithelized area with a 15c blade. | Device | Diode laser group |
| scalpel control groupIn the control group tissue was obtained by two horizontal and two vertical incisions defining the area to be harvested. The blade was oriented perpendicular to the bone along the coronal horizontal incision and once an adequate soft tissue thickness was obtained; it was rotated in order to be parallel to the superficial surface. The thickness of the graft was maintained uniform while proceeding apically with the blade until the FGG was harvested. The palatal wound was protected with equine-derived collagen maintained by compressive sling 5-0 sutures | Procedure or surgery | Scalpel control group |
Primary outcome
Oral health related quality of life
Time frame: 6 months
3 secondary outcomes
Complete root coverage
Time frame: 6 months
Smile related quality of life
Time frame: 6 months
Post-operative Discomfort on the Visual Analog scale
Time frame: 1 month
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 13 May 2015.
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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.
Onur Ozcelik, PhD principal investigator
Cukurova 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 diode laser group in people with Gingival Recession, 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 5 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 13 May 2015. 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?
Oral health related quality of life (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 13 May 2015.