MedPath

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

Phase 2
Conditions
Health Condition 1: O- Medical and Surgical
Registration Number
CTRI/2022/06/043437
Lead Sponsor
Datta Meghe Institute of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. Implant Survival <br/ ><br>2. Implant Success <br/ ><br>3. Mean Bone level as evaluated using radiographTimepoint: At 6 and 12 months from baseline
Secondary Outcome Measures
NameTimeMethod
1. Mean osseointegration period <br/ ><br>2. Dental Plaque Assessment <br/ ><br>3. Papillary Bleeding Index <br/ ><br>4. Periodontal Pocket DepthTimepoint: At 3, 6 and 12 months from baseline
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