Intraseptal and Periodontal Ligament Anaesthesia for Tooth Extraction in Patients With Type 2 Diabetes
Efficacy and Safety of Intraseptal and Periodontal Ligament Anaesthesia for Extraction of Upper Lateral Incisors and Lower First Premolars in Patients With Type 2 Diabetes Mellitus
The goal of this clinical trial is to compare two local anesthesia techniques, intraseptal anesthesia (ISA) and periodontal ligament anesthesia (PLA), in patients with controlled type 2 diabetes mellitus undergoing tooth extraction.
The main questions it aims to answer are:
Which technique provides more effective local anesthesia for tooth extraction? Do ISA and PLA differ in their effects on blood pressure and heart rate during the procedure?
Researchers will compare ISA and PLA to determine which method is more effective and safer in this patient population.
Participants will:
Receive local anesthesia (ISA or PLA) using articaine with epinephrine delivered with a computer-controlled system Undergo extraction of a maxillary lateral incisor or mandibular first premolar Have blood pressure and heart rate measured before, during, and after anesthesia and extraction
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
This randomized clinical trial was designed to evaluate and compare the clinical efficacy and safety of intraseptal anesthesia (ISA) and periodontal ligament anesthesia (PLA) in patients with controlled type 2 diabetes mellitus undergoing tooth extraction.
Local anesthetic administration in diabetic patients requires careful consideration due to potential cardiovascular responses and altered tissue sensitivity. Alternative injection techniques such as ISA and PLA may provide effective anesthesia while minimizing systemic effects.
A total of 120 participants were randomly assigned to receive either ISA or PLA. All anesthetic procedures were performed using a computer-controlled local anesthetic delivery system (CCLADS) with 0.6 mL of 4% articaine with 1:100,000 epinephrine (Septanest).
The study included extraction of maxillary lateral incisors and mandibular first premolars. Outcomes included anesthetic success rate, onset time, duration and extent of anesthesia, as well as changes in systolic and diastolic blood pressure, mean arterial pressure, and heart rate measured before, during, and after the procedure.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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-
Vojvodina
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Pančevo, Vojvodina, Serbia
- Faculty of Dentistry in Pančevo, University of Business Academy in Novi Sad
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Controlled Type 2 diabetes mellitus
- Age 35-77 years
- Patients requiring extraction of maxillary lateral incisors or mandibular first premolars
- Teeth free of acute periodontal disease
- No acute dentoalveolar abscess
- No dental treatment within last 48 hours
- No smoking
- No alcohol or drug dependence
- No contraindications to local anesthetic or vasoconstrictor
Exclusion Criteria:
- Smokers
- Patients with alcohol or drug dependence
- Contraindications to local anesthetics or vasoconstrictors
- Acute periodontal disease at the site of injection
- Acute dentoalveolar abscess
- History of tooth trauma or hypersensitivity in target teeth
- Dental treatment within the last 48 hours prior to procedure
- Non-controlled diabetes mellitus (implied, since study includes controlled DM only
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: ISA (Intraseptal Anaesthesia)
Participants received intraseptal anaesthesia using 0.6 mL of 4% articaine with 1:100,000 epinephrine administered via a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars.
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0.6 mL of 4% articaine with 1:100,000 epinephrine administered for intraseptal anaesthesia (ISA) using a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars.
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Eksperymentalny: PLA (Periodontal Ligament Anaesthesia)
Participants received periodontal ligament anaesthesia using 0.6 mL of 4% articaine with 1:100,000 epinephrine administered via a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars.
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0.6 mL of 4% articaine with 1:100,000 epinephrine administered for periodontal ligament anaesthesia (PLA) using a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Anesthetic success rate
Ramy czasowe: During tooth extraction procedure (5 minutes after administration of local anaesthesia).
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Anesthetic success rate of intraseptal anaesthesia (ISA) compared with periodontal ligament anaesthesia (PLA) during extraction of maxillary lateral incisors and mandibular first premolars in patients with controlled Type 2 diabetes mellitus.
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During tooth extraction procedure (5 minutes after administration of local anaesthesia).
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Onset time of local anesthesia
Ramy czasowe: Immediately after administration of local anesthesia (during procedure)
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Time from completion of anesthetic injection to the establishment of profound anesthesia in adjacent gingival tissue.
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Immediately after administration of local anesthesia (during procedure)
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Duration of soft tissue anesthesia
Ramy czasowe: During and after procedure (measured at 5-minute intervals until sensation returns)
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Time period from onset of anesthesia until return of sensation confirmed by pinprick testing in buccal attached gingiva.
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During and after procedure (measured at 5-minute intervals until sensation returns)
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Width of anesthetic field
Ramy czasowe: 10 minutes after successful anesthesia
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Extent (in millimeters) of anesthetized area in buccal/lingual/palatal attached gingiva and oral mucosa measured using pinprick testing and a flexible ruler.
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10 minutes after successful anesthesia
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Systolic blood pressure changes
Ramy czasowe: Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection
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Changes in systolic blood pressure before, during, and after administration of local anesthesia.
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Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection
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Diastolic blood pressure changes
Ramy czasowe: Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection
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Changes in diastolic blood pressure during perioperative period of anesthesia administration.
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Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection
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Mean arterial pressure changes
Ramy czasowe: Baseline to 30 minutes post-injection
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Changes in mean arterial pressure during and after administration of local anesthesia.
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Baseline to 30 minutes post-injection
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Heart rate changes
Ramy czasowe: Baseline, during injection, and 5, 10, 15, 30 minutes after administration
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Changes in heart rate during and after administration of local anesthesia using ECG monitoring.
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Baseline, during injection, and 5, 10, 15, 30 minutes after administration
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Współpracownicy i badacze
Śledczy
- Główny śledczy: Vladimir Biocanin, Faculty of Dentistry in Pancevo, Department of Oral Surgery, University of Business Academy in Novi Sad, Serbia
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- No.36/3
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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