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

Subepithelial connective tissue graft and injectable platelet-rich fibrin with or without enamel matrix derivative for treating multiple gingival recessions in smokers: a randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/01/030635

Enrollment

Registered

2021-01-20

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Subepithelial connective tissue graft and injectable platelet-rich fibrin with enamel matrix derivative: Dose: surgical intervention (subepithelial connective tissue graft and 5 ml inje

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Gingival recessionTimepoint: Baseline, 6 months and 1 year post-operatively	—

Secondary

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactKunaal Dhingra

AIIMS, New Delhi

kunaaldhingra@yahoo.co.in01126542450

Outcome results