Study to Find Out if a Special Bone-Compacting Drill Can Safely Lift the Sinus membrane and improve Dental Implant Success in the Upper Back Tooth Region

Not Applicable

Not yet recruiting

• Conditions: Atrophy of edentulous alveolar ridge,

• Registration Number: CTRI/2025/05/087422
• Lead Sponsor: Dr Dhanalakshmi P

Brief Summary

This prospective observational clinical study, conducted at Sree Balaji Dental College and Hospital, aims to assess the effectiveness of osseodensification using Densah burs in indirect sinus lift procedures with implant placement. The study focuses on patients with 4-7mm of residual maxillary bone height in the posterior region. It seeks to evaluate improvements in primary implant stability, implant success rates, and a reduction in procedural complications such as sinus membrane perforation. Fourteen patients will be selected based on strict inclusion and exclusion criteria. The procedure involves standard surgical protocols, including local anesthesia, crestal Incision, and osseodensification using Densah burs before implant placement. Patient will be monitored postoperatively at the 3rd,6th and 16th weeks. Assessment will include Resonance Frequency Analysis(RFA) for implant stability and imaging (IOPA and CBCT)for sinus membrane integrity. As an observational study, no additional intervention beyond standard care will be introduced. Ethical approval has been obtained from the institutional review board, and informed consent will be secured from all participants. Data will be analyzed using IBM SPSS software to evaluate outcomes related to implant performance, patient satisfaction, and sinus lift success. The study ensures adherence to ethical guidelines and regulatory compliance throughout

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-05-17
• Study Start: 2025-06-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Diagnosed with a Maxillary vertical height of 4-7 mm in the edentulous area, a minimum width of 4mm, and a sloping sinus floor.
• Edentulous area with tooth present anterior and posterior to it(Molar tooth region) 3.
• Patients with a History of extraction at least before 6 months 4.Decayed tooth.

Exclusion Criteria

• Systemic conditions (like Diabetes and osteoporosis) affecting bone healing.
• Chronic sinusitis or sinus with any other benign pathology 4.
• Pregnant or lactating women.
• Poor Oral Hygiene.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Implant stability,	Immediate and 3rd week
2. Increased Bone Density,	Immediate and 3rd week
3. Faster Healing time	Immediate and 3rd week
4. Implant Success Rate.	Immediate and 3rd week
5. Residual bone height	Immediate and 3rd week
6. Sinus membrane integrity	Immediate and 3rd week

Secondary Outcome Measures

Name	Time	Method
1. Patient Satisfaction	2. Implant Survival Rate

Trial Locations

Locations (1)

Sree Balaji Dental College and Hospital; 🇮🇳 Chennai, TAMIL NADU, India

Sree Balaji Dental College and Hospital

🇮🇳Chennai, TAMIL NADU, India

Dr Dhanalakshmi P

Principal investigator

aishulakshmi21@gmail.com