Management of gum loss using patients own tissue and animal derived material coated with patient blood product

Active, not recruiting

• Conditions: Gingival recession,

• Registration Number: CTRI/2023/08/056045
• Lead Sponsor: Polimera Sanathana

Brief Summary

Gingival recession is defined as a apical migration of gingival margin to the cementoenamel junction exposing the root surface which may lead to dentinal hypersensitivity, root caries and aesthetic concerns to patients. Gold standard treatment protocol for management of gingival recession is the autologous graft obtained from palate. However donor site may not be adequate in all the subjects to manage multiple recessions. The proposed study aims to compare the clinical efficacy of volume stable xenogeneic collagen matrix incorporated with injectable platelet rich fibrin versus de-epithelized gingival graft in the treatment of gingival recession defects. If the intervention group shows similar significant results as the control group, in future  we may recommend the intervention group protocol as a choice of treatment in the patients who don’t have adequate donor tissue and are fearful about second surgical site for procuring graft.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-15
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• 1.Individuals diagnosed with Cairo’s RT1 & RT2 class of recession defects in maxillary anteriors and premolars.
• 2.Sites with minimum depth of recession greater then or equal to 2mm.
• 3.Isolated or multiple adjoining recession involving less than or equal to 3 teeth.

Exclusion Criteria

• Sites with probing pocket depth greater than 4mm.
• 2.Teeth with mobility and/or associated with trauma from occlusion.
• Sites with dental caries and prosthetic restorations.
• Patients who exhibit unacceptable oral hygiene compliance during/or after phase one periodontal therapy.
• Pregnant and lactating women.
• Patient known allergic response with Porcine derived substances.
• Patients with known platelet disorders or using any medication that are known to interfere with platelet function.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To assess & compare the changes in the recession height from baseline to 6 months, within & between the treatment groups.	Baseline, 3 & 6 months
2. To assess & compare the percentage of Complete root coverage achieved at 6months between the treatment groups.	Baseline, 3 & 6 months

Secondary Outcome Measures

Name	Time	Method
1.To assess & compare the changes in the Gingival thickness from baseline to 6 months, within & between the treatment groups.

Trial Locations

Locations (1)

SRM Dental college and Hospital; 🇮🇳 Chennai, TAMIL NADU, India

SRM Dental college and Hospital

🇮🇳Chennai, TAMIL NADU, India

Dr Anupama Tadepalli

Principal investigator

9677065517

anupamamds@gmail.com