Palatal graft substitutes versus palatal graft for soft tissue correction around dental implants in patients with missing upper front teeth.

Volume stable collagen matrix versus connective tissue graft for peri implant soft tissue reconstruction in the maxillary esthetic zone- A randomized controlled noninferiority trial with 3D volumetric and linear outcome assessment - V-COMPARE

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/107549

Enrollment

100

Registered

2026-04-02

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: K051- Chronic gingivitis

Interventions

Intervention1: Volume stable collagen matrix: A platform-switched, bone- or tissue-level single implant system will be used with CAD/CAM zirconia abutments and all-ceramic screw-retained crowns. Minor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Single missing tooth FDI 13 to 24 (incisors, canines, first premolars). 2.Thin buccal mucosa less than or equal to 1.5 mm at implant site (confirmed by calibrated probing or ultrasound). 3.Minor buccal contour defect (visible concavity or flattening). 4.Small buccal bone dehiscence less than or equal to 3 mm. 5.Healed or early placement (Type 2 to 4; no immediate implants). 6.Adequate oral hygiene (FMPS/FMBS less than or equal to 20%).

Exclusion criteria

Exclusion criteria: 1.ASA greater than or equal to III, uncontrolled diabetes, immunosuppression. 2.Major bone augmentation needed (greater than 3 mm defect). 3.Heavy smoking (greater than 10 cigarettes per day). 4.Untreated stage III and stage IV periodontitis.

Design outcomes

Primary

Measure	Time frame
Buccal soft-tissue thickness gain (mm) at 12 months post loading, measured at midbuccal cross section via 3D intraoral scan superimposition (crest plus 2 to 3mm apical points)Timepoint: at 12 months post loading	—

Secondary

Measure	Time frame
3D buccal soft-tissue volume change (mm3) in pre-defined ROITimepoint: at 12 months;Time course of thickness/volumeTimepoint: at 3-4, 6, 12, 24 months;Pink Esthetic Score (PES)Timepoint: at 6, 12 months;White Esthetic Score (WES) and combined PES/WESTimepoint: at 6, 12 months;Jemt Papilla Index (mesial and distal papilla fill)Timepoint: at 6, 12 months;Implant Crown Aesthetic Index (ICAI)Timepoint: at 12 months;Pain (Visual analogue scale)Timepoint: Daily 6hours & 24hours from day 2 to day 7 postoperatively;Analgesic consumption (tablet count)Timepoint: Day 0 to day 7 postoperative;OHIP-14Timepoint: at baseline, 12 months;Peri-implant health: probing depth (PD), bleeding on probing (BoP), suppuration, peri-implant mucosal recession, modified plaque index (mPI), and modified bleeding index (mSBI).Timepoint: at baseline & 12months post-loading;Keratinised mucosa width (mm)Timepoint: at baseline & 12 months post-loading;Marginal bone level changes (radiographic)Timepoint: at baseline & 12 months post-loading;Complications (wound dehiscence, exposure, infection, implant failure)Timepoint: at baseline and 12 months post-loading;Surgeon handling scores (5-point Likert)Timepoint: day 0;Phenotype conversionTimepoint: at baseline and 12 months post-loading	—

Measure

Time frame

3D buccal soft-tissue volume change (mm3) in pre-defined ROITimepoint: at 12 months;Time course of thickness/volumeTimepoint: at 3-4, 6, 12, 24 months;Pink Esthetic Score (PES)Timepoint: at 6, 12 months;White Esthetic Score (WES) and combined PES/WESTimepoint: at 6, 12 months;Jemt Papilla Index (mesial and distal papilla fill)Timepoint: at 6, 12 months;Implant Crown Aesthetic Index (ICAI)Timepoint: at 12 months;Pain (Visual analogue scale)Timepoint: Daily 6hours & 24hours from day 2 to day 7 postoperatively;Analgesic consumption (tablet count)Timepoint: Day 0 to day 7 postoperative;OHIP-14Timepoint: at baseline, 12 months;Peri-implant health: probing depth (PD), bleeding on probing (BoP), suppuration, peri-implant mucosal recession, modified plaque index (mPI), and modified bleeding index (mSBI).Timepoint: at baseline & 12months post-loading;Keratinised mucosa width (mm)Timepoint: at baseline & 12 months post-loading;Marginal bone level changes (radiographic)Timepoint: at baseline & 12 months post-loading;Complications (wound dehiscence, exposure, infection, implant failure)Timepoint: at baseline and 12 months post-loading;Surgeon handling scores (5-point Likert)Timepoint: day 0;Phenotype conversionTimepoint: at baseline and 12 months post-loading

—

Countries

India

Contacts

Public ContactNeelima Katti

SCB Dental College and Hospital

kattineelima@gmail.com9337613446

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026