Use of a gum graft from palate or a dressing processed from animal skin for improving gum tissue height around dental implants

Comparison of clinical outcomes, histomorphometric and gene expression analysis of connective tissue graft with two types of xenogeneic matrices for peri-implant vertical soft tissue augmentation - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/077176

Enrollment

Registered

2024-11-21

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

Health Condition 1: K068- Other specified disorders of gingiva and edentulous alveolar ridge

Interventions

Intervention1: Commercially available bioresorbable volume stable collagen matrix (Fibrogide®): It is made of 60-90% (w/w) porcine collagen type I and III and 4-40% (w/w) elastin. It will be sutured a

Eligibility

Inclusion criteria

Inclusion criteria: (j) Systemically healthy individuals over 18 years of age (k) Healthy periodontium or demonstrating stable periodontal condition following conventional periodontal therapy. (l) Full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) of less than 15 percent (m) Presence of single missing posterior tooth indicated for implant-supported prosthesis (n) Thin mucosal tissues , less than or equal 2 mm in vertical dimension i.e. covering the edentulous alveolar ridge (o) Minimum of 6 mm width and 8 mm height of available bone. (p) Presence of minimum 4 mm of keratinized tissue buccolingually (q) No need of bone augmentation procedure before and during implant placement (r) Provide consent for the use of soft tissue matrix of porcine origin

Exclusion criteria

Exclusion criteria: (a) Insufficient inter-arch space for implant-supported crown (b) Inability or anticipated failure to maintain adequate oral hygiene (c) Pregnancy or lactating moth¬ers (d) Patients with other systemic conditions (uncontrolled diabetes, unstable bleeding disorders, active infectious diseases; hepatitis, tuberculosis, HIV etc.) that could affect the healing ability of wound. (e) Mental disabilities that may hinder participation. (f) History of active immunosuppressive therapy, cancer therapy and/or radiation to the oral cavity. (g) Patients taking medications that affect the healing of soft tissues (e.g. NSAIDs, steroids, etc.). (h) Smokers or tobacco usage in any form

Design outcomes

Primary

Measure	Time frame
1. Vertical soft tissue thickness gain 2. Histological assessment of grafted tissue 3. Gene expression profile of grafted tissueTimepoint: 3 months	—

Secondary

Measure	Time frame
Duration of Surgery Post-operative Pain Timepoint: Immediate and 2 weeks respectively	—

Countries

India

Contacts

Public ContactDr Vikender Singh

AIIMS, New Delhi

vikenderyadav@gmail.com8800798248

Outcome results

None listed

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