Comparing clonidine-enhanced lignocaine and adrenaline-enhanced lignocaine for hemodynamic stability and analgesic outcomes in mandibular molar extractions- A randomised controlled trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Time of onset and duration of action - In this, we will assess the time of onset of a drug and how long it takes to start working after administration and assess the duration of action of drug, which refers to the effectiveness of the drug in the body after
Study Overview
Brief Summary
This prospective clinical study aims to evaluate the clinical and esthetic outcomes of lip repositioning surgery using diode laser versus conventional scalpel technique in patients with excessive gingival display (gummy smile). Conducted in a single center, the randomized trial will include patients aged 18–45 years diagnosed with excessive gingival display due to hypermobile upper lip or altered passive eruption. Outcomes will be assessed using standardized photographic analysis and patient-reported esthetic satisfaction over a 6-month follow-up. The study will compare post-operative healing, complications, and esthetic results to determine the more effective technique for managing gummy smiles
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Age 20–60 years 2.ASA (American Society of Anaesthesiologists) physical status I and II 3.No known allergies to lignocaine, clonidine, or adrenaline 4.Presence of dental caries, periapical abscess, or periodontitis requiring extraction 5.Simple, non-complicated extractions.
Exclusion Criteria
- •1.Patients on medications that may affect healing (e.g., steroids, anticoagulants) 2.Pregnant or lactating women 3.Patients with bleeding disorders or previous history of extractions 4.Patients with impacted or submerged teeth 5.Patients with a history of smoking, alcohol consumption, or substance abuse.
- •6.Impacted and unerupted tooth.
Outcomes
Primary Outcomes
Time of onset and duration of action - In this, we will assess the time of onset of a drug and how long it takes to start working after administration and assess the duration of action of drug, which refers to the effectiveness of the drug in the body after
Time Frame: 10 min before anaesthesia,10 min after anaesthesia,30 min after surgical procedure
administration.
Time Frame: 10 min before anaesthesia,10 min after anaesthesia,30 min after surgical procedure
Hemodynamic parameters (Blood Pressure, Mean Arterial Pressure) will be assessed
Time Frame: 10 min before anaesthesia,10 min after anaesthesia,30 min after surgical procedure
by Digital Sphygmomanometer
Time Frame: 10 min before anaesthesia,10 min after anaesthesia,30 min after surgical procedure
Heart Rate and SpO: will be assessed by pulse oximeter.
Time Frame: 10 min before anaesthesia,10 min after anaesthesia,30 min after surgical procedure
Secondary Outcomes
- • Post Operative Rescue Analgesics- Time until the initial dose of rescue analgesic following the administration of local anaesthetic.(• Patient-reported pain scores (VAS scale)- The Visual Analog Scale (VAS) is a simple, continuous measurement tool used to assess subjective experiences like pain or emotions.)
Investigators
DR AKHOURI PRAKHAR SINHA
KOTHIWAL DENTAL COLLEGE AND RESEARCH CENTRE