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A clinical trial to evaluate dental implants in smoker patients.

Evaluation of Dental implants with Platelet rich in growth factors (PRGF) in smokers: A split mouth randomised controlled clinical trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/12/060668
Enrollment
20
Registered
2023-12-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K068- Other specified disorders of gingiva and edentulous alveolar ridge

Interventions

Intervention1: Maintained Active Implant with platelet rich in growth factors (PRGF).: Test Site- -Maintained Active Implant are spiral design implants but with innovative hollowed platform and with f

Sponsors

Dr Aastha Singh
Lead Sponsor
King George Medical University
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Moderate smokers ( >10 and 2. Healed sites without bone grafting / bone defects for at least 3 months. 3. Periodontally healthy teeth adjacent to the implant sites and without any periapical lesion. 4. Identical edentulous spaces in either of the arches with adequate bone volume.

Exclusion criteria

Exclusion criteria: 1. Patients consuming any other form of tobacco other than cigarette smoking and alcohol consumption. 2. Pregnant and breast-feeding females. 3. Immunosuppressive health or any systemic disease or disorder like diabetes mellites, immune-viral diseases, hepatic and renal diseases, bone related disorders etc. 4. Subjects with local or systemic drug use like bisphosphonates, NSAID’S antibiotics or corticosteroids etc. from last 3 months. 5. Bruxism or other oral para functional habits. 6. Subjects with history of any surgical or peri-implant treatment. 7. Maligned teeth or edentulous patients.

Design outcomes

Primary

MeasureTime frame
Healing of peri-implant soft tissues and marginal bone loss especially in cases of smokers by modification of implant design along with PRGF to shorten the healing time and bone and implant contact. Timepoint: Dividing patient visits in following stages: - 1-Fixture placement along with PRGF at test site and control site with conventional fixture only. Baseline recordings. 2.At 1 month, PRGF will be injected at site with MAI implant only. 3.At 3-4 months abutment placement. 4.At 6 months after loading.—

Secondary

MeasureTime frame
•To evaluate aesthetic outcomes. •Patient compliance and experience. Timepoint: - Aesthetic outcomes: • Pink esthetic score • White esthetic score -Post operative pain and healing after 24 hours of surgery, 1weeks and at 1month follow up period.—

Countries

India

Contacts

Public ContactDr Aastha Singh

King George Medical University.

uspal@kgmcindia.edu9415006417

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026