Health Condition 1: K050- Acute gingivitis Health Condition 2: F172- Nicotine dependence
Conditions
Interventions
Intervention1: test group 1: smoker Patients with isolated edentulous receiving Hydrophilic implants (Sand blasted large grid acid etched implants with aqua surface - SLA active)
Intervention2: test g
Sponsors
C ANNE KIRUBA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged between 25 and 60 years will be included in the study 2. One bounded edentulous space i.e., a single tooth missing with intact proximal teeth primarily in the lower posteriors (premolars and molars) with sufficient bone quantity to allow implant placement. 3. Patients should be cooperative, motivated and oral hygiene conscious. 4. Only patients with adequate bone height of at least 13 mm and bone width of at least 6 mm will be included. 5. Patients with healthy adjacent teeth and stable periodontal status will be considered for inclusion. 6. current smokers were included only if their exposure was classified as mild, defined as fewer than 10 cigarettes per day and a cumulative history of less than 0.5 pack-years.
Exclusion criteria
Exclusion criteria: 1. Patients with uncontrolled systemic diseases such as diabetes, immunocompromised conditions, or bleeding disorders. 2. Patients who have a history of taking bisphosphonates, corticosteroids, immunosuppressive drugs, or anticoagulants will be excluded. 3. Patients with active periodontal disease or untreated oral infections will be excluded. 4. Patients who require bone grafting or ridge augmentation procedures will be excluded. 5. Patients exhibiting parafunctional habits such as bruxism or clenching will be excluded. 6. Pregnant or lactating women will be excluded from the study. 7. Patients who have undergone radiotherapy in the head and neck region or chemotherapy will be excluded. 8. Patients with known allergy to titanium or implant-related materials will be excluded. 9. Patients who are unwilling or unable to comply with oral hygiene instructions will be excluded. 10. Patients with a history of failed implant placement at the intended site will be excluded. 11. Patients who do not comply for 1 year follow up are excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Mean Crestal bone level changes (mm) to be assessed at Baseline and 1 year with standardized Intra oral periapical radiographs in Control (SLA) and Test groups (SLA-Active & LMGI). 2) Implant survival rates (%) to be assessed at 1 year with radiographic and clinical assessment between Control (SLA) and Test groups (SLA Active & LMGI). Timepoint: baseline and 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate and compare the Relative position of gingival margin (mm) at the implant site of Control (SLA) and Test groups (SLA-Active and LMGI) at Baseline, 6 months and 1 year post loadingTimepoint: baseline , 6 months and 1 year;2. To assess the Implant stability quotient (ISQ) values using resonance frequency analysis (RFA) during Early Loading protocol. 3. To assess the Early Wound Healing Index (EWHI) using Huang et al index (2005) at the 1st week, 2nd week, and 4th week during the Early Loading protocol, comparing the Control (Hydrophobic) and Test groups (Hydrophilic and Laser Micro-Grooved Implants). 4. To assess and compare Patient Reported Outcome Measures (PROMs) like pain scale using Visual Analog Scale at 1 week Timepoint: 1st week, 2nd week, 4th week, 6 months and 1 year | — |
Countries
India
Contacts
Public ContactDr PSG Prakash
SRM Dental college , Ramapuram
Outcome results
None listed