- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07653802
Comparison of Er:YAG Assisted Laser Crown Lengthening Against Surgical Crown Lengthening
Comparison of Er:YAG Assisted Laser Crown Lengthening Against Surgical Crown Lengthening: a Longitudinal Study.
Study Overview
Status
Conditions
Detailed Description
Crown lengthening is a clinical procedure that involves reshaping the gingiva, and sometimes bone, in order to expose more of tooth's structure. The procedures is performed for both functional and aesthetic reasons. In certain instances, this procedure is performed to This procedure is commonly performed for both functional and aesthetic reasons, such as to prepare a tooth for a crown or to enhance the appearance of a smile. Traditional crown lengthening techniques typically involve surgical methods that can be invasive, leading to extended recovery times and postoperative discomfort in this study we compare traditional versus the laser aided crown lengthening to compare the periodontal parameters in both cases.
Laser technology and minimally invasive therapy have become increasingly prominent in various dental fields. The erbium:YAG laser, the newest type, can be used on both soft and hard tissues. This study evaluates the periodontal outcomes of a flapless crown lengthening procedure using the erbium:YAG laser in comparison to traditional methods.
Crown lengthening aims to obtain a larger crown surface by surgical means either by gingivectomy or by recontouring of the cortical bone. The obtained increased crown surface can be used to build crowns.
Conventional surgical techniques involve incisions, elevation of flap and osteoplasty. Subsequently, the flaps are approximated and sutured.
LASER stands for Light amplification by stimulated emission of radiation. Several lasers are used in dentistry including soft and hard tissue lasers. Soft tissue lasers including diode lasers are used to incise the soft tissue, whereas lasers including Er:YAG lasers hard tissue lasers can be used to Er:YAG lasers are known to have good cutting and coagulation abilities on soft tissues.(1) Upon use in soft tissues the laser provides good coagulation resulting in bleeding control. The laser is capable of Lasers offer significant advantages including reduced bacteraemia, reduced post operative discomfort, improved bleeding control and quicker healing. The comfort of avoiding a surgical procedure is an added advantage which may make the patient less concerned about opting for treatment options.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nesma Shemais
- Phone Number: 0529961988
- Email: dr.nesma@gmu.ac.ae
Study Locations
-
-
Ajman Emirate
-
Ajman, Ajman Emirate, United Arab Emirates, 00000
- Recruiting
- Gulf Medical University
-
Contact:
- Nesma Shemais, PhD
- Phone Number: 0529961988
- Email: dr.nesma@gmu.ac.ae
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Teeth indicated for crown lengthening procedure either in the maxillary or mandibular arch.
- Patients in the age group of 18-75 years.
Exclusion criteria:
- Patients with uncontrolled diabetes mellitus. Uncontrolled diabetes mellitus diagnosed with HbA1C ≥ 7% will be an exclusion criterion.
- Smokers (considered as smoking ≥ 10 cigarettes/day)
- Pregnant women
- Patients with uncontrolled systemic diseases that may affect the healing of soft and hard tissues of the periodontium will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: crown lengthening using Er:YAG Laser
Er:YAG laser is used for both soft and hard tissue recontouring according to the manufacturer's guidelines.
In the case of gingivectomy and soft tissue recontouring, 4x17mm, 0.6x17mm, and 1.3x17mm tips are used, and the soft tissue mode is selected on the device screen, which sets the device parameters to 100mJ x 20Hz.
The tip is in direct contact with the soft tissue until the desired soft tissue level is achieved.
For bone contouring, the hard tissue option is selected on the device's screen, setting the parameters to 150mJ x 20Hz.
A non-contact approach is used to reshape the underlying bone.
|
Er:YAG laser is used for both soft and hard tissue recontouring according to the manufacturer's guidelines.
In the case of gingivectomy and soft tissue recontouring, 4x17mm, 0.6x17mm, and 1.3x17mm tips are used, and the soft tissue mode is selected on the device screen, which sets the device parameters to 100mJ x 20Hz.
The tip is in direct contact with the soft tissue until the desired soft tissue level is achieved.
For bone contouring, the hard tissue option is selected on the device's screen, setting the parameters to 150mJ x 20Hz.
A non-contact approach is used to reshape the underlying bone.
|
|
Active Comparator: : conventional surgical crown lengthening by opening envelop flap
Bevel incision with number 15 blades is place on the margin following with sulcular incision and excess gingival tissues are removed using Gracey currets .in case if any granulation tissues are seen it should be removed and washed with saline. Following with bone recontouring and reshaping after periosteal elevator is used to expose the underlying bone. fissure burs or coarse diamond stones are used until thing bone tissues are left over the root and rest can be removed with scaler to prevent damage to the tooth. Resorbable sutures are place after the surgery and the case is followed up for 3 months period. In the case of conventional surgical crown lengthening, after delivering the local anesthetic solution to the surgical area, soft tissue recontouring starts. This procedure, which involves excising the soft tissue with a gingivectomy, is typically done to improve aesthetics or create more space for better restoration seating. The gingival border is typically 1 mm coronal to the CEJ |
Bevel incision with number 15 blades is place on the margin following with sulcular incision and excess gingival tissues are removed using Gracey currets .in case if any granulation tissues are seen it should be removed and washed with saline. Following with bone recontouring and reshaping after periosteal elevator is used to expose the underlying bone. fissure burs or coarse diamond stones are used until thing bone tissues are left over the root and rest can be removed with scaler to prevent damage to the tooth. Resorbable sutures are place after the surgery and the case is followed up for 3 months period. In the case of conventional surgical crown lengthening, after delivering the local anesthetic solution to the surgical area, soft tissue recontouring starts. This procedure, which involves excising the soft tissue with a gingivectomy, is typically done to improve aesthetics or create more space for better restoration seating. The gingival border is typically 1 mm coronal to the CEJ. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain
Time Frame: baseline, 3 days
|
VAS 0-10
|
baseline, 3 days
|
|
Postoperative pain
Time Frame: baseline 3 days
|
VAS scale 0-10
|
baseline 3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Probing depth
Time Frame: baseline, 3 months , 6 months
|
baseline, 3 months , 6 months
|
|
|
patient satisfaction VAS
Time Frame: baseline, 3 days , 6 months
|
VAS 0-10
|
baseline, 3 days , 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Ali-MDSperio
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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