Laser De-epithelialization for Epithelial Exclusion in Root Coverage Procedure: a Clinical Study

Study Overview
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Brief Summary
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The concept of laser deepithelialization to retard epithelial migration has enabled new attachment formation in periodontal pockets. Based on this hypothesis, that laser deepithelialization during root coverage procedures will enhance clinical outcome, a split mouth randomized controlled clinical trial was planned to compare the clinical outcome of Coronally advanced flap (CAF) + subepithelial connective tissue graft (SCTG) alone and in combination with laser de-epithelialization in the treatment of gingival recession.

Detailed Description
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Successful treatment of recession defects to obtain new attachment and prevent repair by long junctional epithelium continues to present a serious therapeutic challenge. The concept of laser deepithelialization to retard epithelial migration has enabled new attachment formation in periodontal pockets. Based on this hypothesis, that laser deepithelialization during root coverage procedures will enhance clinical outcome, a split mouth randomized controlled clinical trial was planned to compare the clinical outcome of Coronally advanced flap (CAF) + subepithelial connective tissue graft (SCTG) alone and in combination with laser de-epithelialization in the treatment of gingival recession. METHOD: In a split-mouth study, 20 patients presenting at least one pair of bilaterally symmetrical Miller's Class I and Class II buccal gingival recessions will be selected. Control site will receive coronally advanced flap with connective tissue graft and test site will receive laser deepithelialization as an adjunct to coronally advanced flap with connective tissue graft. Gingival recession depth (GRD), Gingival recession width (GRW), Probing depth (PD), Clinical attachment level (CAL), Keratinized tissue width (KTW), Plaque index (PI), Gingival index (GI), Gingival bleeding index (GBI) will be measured at baseline, 6 weeks, 3 months and 6 months after treatment. The root coverage outcomes were also assessed by photogrammetric analysis.

Official Title
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Laser De-epithelialization for Epithelial Exclusion in Root Coverage Procedure: a Clinical Study

Conditions
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Gingival Recession

Intervention / Treatment
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* Device: LASER deepithelialization
* Device: Sham LASER deepithelialization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:• Miller's Class I and II recession defects involving maxillary or mandibular canines or premolars. Similar bilateral recession defects. Systemically healthy patients. Patients willing to participate in study. Age group of 21-57 years. Patients with esthetic concerns. Exclusion Criteria: Pregnant and lactating woman Patients who have undergone any type of regenerative periodontal therapy six months prior to the initial examination. Patients with history of smoking. Teeth with hopeless prognosis. Root surface restoration.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 57 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CAF+ SCTG+ laser depithelialisation<br>CAF + SCTG and Diode (GaAlAs) laser with a wavelength of 820 nm and a power of 1.5 watt in a continuous mode was applied to remove the sulcular epithelium. | Device: LASER deepithelialization<br>* the selected participants were assigned in test and control. Under LA full thickness flap was reflected until the mucogingival junction and recipient area was prepared. The connective tissue graft harvested from palate was placed on the root surface and secured with 5-0 absorbable sutures. Diode (GaAlAs) laser with a wavelength of 820 nm and a power of 1.5 watt in a continuous mode was applied to remove the sulcular epithelium. The connective tissue graft was placed on the root surface at the level of the CEJ and then secured with 5-0 absorbable sutures in both test and control sites using sling suture..<br>|
| Sham Comparator: CAF+SCTG+ sham laser depithelialisation<br>CAF+ SCTG+ sham LASER deepithelialisation was applied to remove the sulcular epithelium. | Device: Sham LASER deepithelialization<br>* the selected participants were assigned in test and control. Under LA full thickness flap was reflected until the mucogingival junction and recipient area was prepared. The connective tissue graft harvested from palate was placed on the root surface and secured with 5-0 absorbable sutures. sham LASER deepithelialisation was applied to the sulcular epithelium. The connective tissue graft was placed on the root surface at the level of the CEJ and then secured with 5-0 absorbable sutures in both test and control sites using sling suture..<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of root coverage (PRC) |  | 6 months | 
| Complete root coverage |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reductions in recession depth (Rec Red) |  | 6 months | 
| Gingival recession width (GRW) |  | 6 months | 
| Probing depth (PD) |  | 6 months | 
| Clinical attachment level (CAL) |  | 6 months | 
| Keratinized tissue width (KTW) |  | 6 months |