A clinical trial to evaluate dental implants in smoker patients.

Not yet recruiting

• Conditions: Other specified disorders of gingiva and edentulous alveolar ridge,

• Registration Number: CTRI/2023/12/060668
• Lead Sponsor: Dr Aastha Singh

Brief Summary

There are various options for regeneration of bone around the implant like autogenous bone graft, demineralized freeze-dried bone (DFDB), Platelet rich in growth factors (PRGF) etc. autogenous bone graft have drawback of donor site morbidity, DFDB is more prone to infection and rejection while PRGF is one of the promising choices which is having least complications with no donor site morbidity. Apart from other qualities economically it seems to be the best choice till date. So, in this study we have chosen PRGF and are going to evaluate its efficacy in bone formation. A systematic review also suggested that Platelet rich fibrin might enhance implant stability during early phase of osseointergration (Strauss et al. 2018).

Many attempts have been made to attain ultimate primary as well as secondary stability (osseointegration) by modifying macro as well as micro design of dental implants. Recently, Maintained Active Implants (MAI) has been introduced which is based on spiral design implants but with innovative hollowed platform and with few points of holes in the body to deliver regenerative substances to ensure bone preservation and internal osseointegration with years to come. However, there is lacunae in the available literature regarding the PRGF delivery at the healing site and its outcome by this design of dental implant. From this we try to overcome the limitations of the available dental implants in healing of peri-implant soft tissues and marginal bone loss especially in cases of smokers which have high prevalence of implant failure.

Few literatures, especially split mouth randomised controlled trial, are available to overcome the adverse effects of smoking, PRGF is used and its effect on peri-implant soft tissues, marginal bone loss and to establish primary stability that is crucial phase for implant survival. So, we are attempting to evaluate the effect of PRGF on bony and soft tissue integration of the dental implant in moderate cigarette smokers. In this study delivery system of the regenerative material and implant design is different from the studies conducted till date.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-12-20
• Study Start: 2024-01-22

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Moderate smokers (>10 and <20 cigarettes per day from last 10 years) who is willing to quit smoking.
• Healed sites without bone grafting / bone defects for at least 3 months.
• Periodontally healthy teeth adjacent to the implant sites and without any periapical lesion.
• Identical edentulous spaces in either of the arches with adequate bone volume.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
•To evaluate aesthetic outcomes.	•Patient compliance and experience.

Trial Locations

Locations (1)

New Dental Building, King George Medical University, Lucknow -226003, India; 🇮🇳 Lucknow, UTTAR PRADESH, India

New Dental Building, King George Medical University, Lucknow -226003, India

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Aastha Singh

Principal investigator

9169158477

aastha.singh17891@gmail.com