NCT07597135

Brief Summary

This study will evaluate the efficacy of Alb PRF membrane in comparison to a subepithelial connective tissue graft in the reconstruction of interdental papillae.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_3

Timeline
30mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 20, 2026

Expected
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2028

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2028

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

2.3 years

First QC Date

May 13, 2026

Last Update Submit

May 13, 2026

Conditions

Deficient Interdental Papilla

Keywords

interdental papilla

Outcome Measures

Primary Outcomes (1)

  • papillary height measured from apical part of contact point to tip of papilla (CP-TP)

    from enrollment, 3 months, 6months, 9months, 12months

Study Arms (2)

connective tissue graft

ACTIVE COMPARATOR
Biological: connective tissue graft

Albumin plasma rich fibrin membrane

EXPERIMENTAL
Biological: Albumin (5% serum-protein solution containing immunoglobulins)

Interventions

Albumin (5% serum-protein solution containing immunoglobulins)BIOLOGICAL

a variation of PRF done by heating up to 75 degree then mixed with the remaining prf to get membrane

Albumin plasma rich fibrin membrane
connective tissue graftBIOLOGICAL

subepithelial connective tissue graft

connective tissue graft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • inter dental papilla deficincy

You may not qualify if:

  • smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Albumins

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

May 13, 2026

First Posted

May 19, 2026

Study Start (Estimated)

June 20, 2026

Primary Completion (Estimated)

September 20, 2028

Study Completion (Estimated)

December 20, 2028

Last Updated

May 19, 2026

Record last verified: 2026-05