Scalpel Versus Laser Gingivectomy in Orthodontic Patients in the Management of Periodontal Health
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|ClinicalTrials.gov Identifier: NCT03514316|
Recruitment Status : Completed
First Posted : May 2, 2018
Last Update Posted : May 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Orthodontic Appliance Complication Gingival Overgrowth||Procedure: Scalpel Gingivectomy Procedure: Laser Gingivectomy Procedure: Nonsurgical periodontal treatment||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||a prospective three-arm parallel group randomized clinical trial with 1:1:1 allocation ratio|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The observer who performed all the measurements was blinded to the group assignment. The study was blinded in regard to the statistical analysis: blinding was obtained by eliminating from the elaboration file every reference to patient group assignment.|
|Official Title:||Scalpel Versus Laser Gingivectomy in the Management of Periodontal Health During Orthodontic Treatment: a Randomized Controlled Clinical Trial|
|Actual Study Start Date :||February 1, 2017|
|Actual Primary Completion Date :||February 28, 2018|
|Actual Study Completion Date :||February 28, 2018|
Active Comparator: Scalpel Gingivectomy
Patients treated with Scalpel Gingivectomy on the labial side of the anterior maxillary teeth
Procedure: Scalpel Gingivectomy
The patients were anesthetized in the area around the teeth which were to undergo the procedure with local anesthesia (Drug: 2% lidocaine and 1:80,000 adrenaline). Initially, the Periodontal Probing Depth was measured and when sufficient anesthesia was achieved, biologic width calculation was done by the trans-gingival probing method. Once the amount of gingival tissue to be excised was demarcated, an external bevel incision was performed by using a scalpel blade (Device: scalpel blade No.15) and the gingival tissue was excised. Left out tissue tags and any beads of granulations tissue were removed to attain a smooth surface.
Active Comparator: Laser Gingivectomy
Patients treated with Laser Gingivectomy on the labial side of the anterior maxillary teeth
Procedure: Laser Gingivectomy
In the Laser Gingivectomy group, the procedure was performed by using a 810 nm diode laser (Device: 810 nm FOX III diode laser) . Though a local anesthetic gel is sufficient considering that the procedure is minimally invasive, the area was adequately anesthetized with 2% lidocaine and 1:80,000 adrenaline. The laser unit, comprising of a 300 μm disposable tip, was used in a contact mode with a setting of 1 to 1.5 watts in continuous mode along the demarcated area with a paint brush like strokes progressing slowly to remove the gingival tissue and expose adequate amount of tooth structure. High-volume suction was used to evacuate the laser plume and charred odor
Active Comparator: Nonsurgical periodontal treatment
Patients treated with a full-mouth periodontal debridement
Procedure: Nonsurgical periodontal treatment
In all subjects of the Control Group a full-mouth periodontal debridement was performed at baseline, 1 and 3 months with an ultrasonic scaler. Chlorhexidine prophylaxis (0.05% chlorhexidine gluconate) was also administered twice a day for 2 weeks after the periodontal treatment. Oral-hygiene instructions were reinforced again.
- Probing Pocket Depth Changes after Scalpel Gingivectomy vs Laser Gingivectomy compared with a Control Group receiving non surgical periodontal treatment only at 3 time points respect to baseline. [ Time Frame: 6 months ]
The primary outcome is the reduction of the Pocket Depth. The objective is to evaluate the change in the Pocket Depth induced by Scalpel Gingivectomy or Laser Gingivectomy, compared with a nonsurgical periodontal treatment group at 3 time points respect to baseline: 1 month, 3 months and 6 months.
Probing Pocket Depths (PPDs) were recorded at baseline to determine the biologic width and to assess how much tissue could be contoured without involving osseous surgery, using a North Carolina periodontal probe; Scalpel Gingivectomy or Laser Gingivectomy were performed in the treated groups.
In the non surgical periodontal treatment group, full-mouth periodontal debridement was performed at baseline, 1 and 3 months with an ultrasonic scaler.
Overall patient data were calculated as mean value by averaging measurements in all sites of six upper anterior teeth.
- Increased Clinical Crown Length (CCL) after Scalpel Gingivectomy vs Laser Gingivectomy [ Time Frame: 6 months ]
The secondary outcome is the increase of the CCL, measured as the distance between incisal edge and gingival margin along the tooth long axis.
The objective is to evaluate the change in the CCL induced by Scalpel Gingivectomy or Laser Gingivectomy, compared with a nonsurgical periodontal treatment group.
All measures were repeated at 1, 3 and 6 months post-surgery or full-mouth periodontal debridement. Overall patient data were calculated as mean value by averaging measurements of six upper anterior teeth.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514316
|Department of Orthodontics, Department of Clinical Sciences and Translational Medicine, University of Rome "Tor Vergata".|
|Roma, Italy, 00133|
|Principal Investigator:||Andrea Noviello||Department of Orthodontics, Department of Clinical Sciences and Translational Medicine, University of Rome "Tor Vergata," Rome, Italy|