- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Nesma Shemais
- Telefonní číslo: 0529961988
- E-mail: dr.nesma@gmu.ac.ae
Studijní místa
-
-
Ajman Emirate
-
Ajman, Ajman Emirate, Spojené arabské emiráty, 00000
- Nábor
- Gulf Medical University
-
Kontakt:
- Nesma Shemais, PhD
- Telefonní číslo: 0529961988
- E-mail: dr.nesma@gmu.ac.ae
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
|
Aktivní komparátor: : 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Postoperative Pain
Časové okno: baseline, 3 days
|
VAS 0-10
|
baseline, 3 days
|
|
Postoperative pain
Časové okno: baseline 3 days
|
VAS scale 0-10
|
baseline 3 days
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Probing depth
Časové okno: baseline, 3 months , 6 months
|
baseline, 3 months , 6 months
|
|
|
patient satisfaction VAS
Časové okno: baseline, 3 days , 6 months
|
VAS 0-10
|
baseline, 3 days , 6 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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