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Clinical trial for treating gums recession in smokers using patients own gum tissue and blood with or without synthetic growth factor

Phase 3
Registration Number
CTRI/2021/01/030635
Lead Sponsor
AIIMS New Delhi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Age more than or equal to 18 years

2. Smokers (light/moderate and heavy smokers based on pack-years consumption)

3. Absence of relevant medical conditions

4. Presence of more than or equal to 3 adjacent multiple Millerâ??s class I and II gingival recession defects on both sides of the maxillary or mandibular arch with an apico-coronal extension (i.e. recession depth) > 2 mm

5. Patient willing to participate in the study

Exclusion Criteria

• Pregnant or lactating females

• Non-smoker

• Uncontrolled medical conditions

• Use of systemic antibiotics in the past 3 months

• Use of systemic antibiotics for endocarditis prophylaxis

• Patients treated with any medication known to affect gingival conditions (e.g. hyperplasia)

• Infectious diseases such as hepatitis, tuberculosis, COVID-19 and HIV

• Drug and alcohol abuse

• Failure to sign written informed consent

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Gingival recessionTimepoint: Baseline, 6 months and 1 year post-operatively
Secondary Outcome Measures
NameTimeMethod
probing depth (PD), gingival recession (REC) and clinical attachment level (CAL), width of keratinized gingiva (KGW), width of recession defect (RW) and the distance between the contact point and the top of the papilla at the mesial aspect of the tooth (DCP)Timepoint: Baseline, 6 months and 1 year post-operatively
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