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A randomized controlled clinical trial to evaluate the clinical efficacy of indigenously designed and produced titanium dental implant

Evaluation and Comparison of clinical efficacy of indigenously designed and produced titanium dental implant system with hybrid threads and anti-rotational features with Straumann implant: A randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/06/043437
Enrollment
24
Registered
2022-06-22
Start date
Unknown
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: The new titanium implant system: The new implant system with a tapered screw profile of 4.7 mm diameter and 12 mm-6 mm length will be used for implantation. The implant system will be p

Sponsors

Datta Meghe Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Absence of one/two tooth bilaterally in maxilla or mandible 2. Periodontal Healthy Adults above 18 years of age 3. Good general health of the individuals whose ASA score is 1-2 4. Absence of systemic diseases. 5. Sufficient bone volume with 4 months post- extraction healing time 6.Patient giving his/her informed consent and willing to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Immunocompromised patients 2. Poor oral hygiene 3. Adults with parafunctional habits like bruxism etc. 4. Adults with allergy to titanium or titanium alloys. 5. Pregnant woman or breastfeeding. 6. Heavy smoker; more than 10 cigarettes in a day. 7. Patients on systemic corticosteroids for long term 8. Patients with history of radiation therapy in the head and neck region. 9. Refusal of patient to participate in the study.

Design outcomes

Primary

MeasureTime frame
1. Implant Survival 2. Implant Success 3. Mean Bone level as evaluated using radiographTimepoint: At 6 and 12 months from baseline

Secondary

MeasureTime frame
1. Mean osseointegration period 2. Dental Plaque Assessment 3. Papillary Bleeding Index 4. Periodontal Pocket DepthTimepoint: At 3, 6 and 12 months from baseline

Countries

India

Contacts

Public ContactDr Bhairavi Kale

Datta Meghe Institute of Medical Sciences

priyanka.banode@gmail.com9960713010

Outcome results

None listed

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