NCT06842277

Brief Summary

The goal of this ( A case series, clinical trial ) is treatment of deficient interdental papilla in patients who have interdental papillary loss class 1 or 2 in maxillary or mandibular anterior region with plaque index and gingival index less than 1 and the selected sites had distance between contact point and inter proximal bone crest less than 7mm and probing depth less than 4mm. Hypothesis: Albumin-PRF is an efficient treatment of deficient interdental papilla. The primary outcome ( distance between the contact point and papillary tip will be measured by periodontal probe) The participants will practice good oral hygiene measures

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 18, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 19, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 24, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

11 months

First QC Date

February 19, 2025

Last Update Submit

February 22, 2025

Conditions

Keywords

Reconstruction of deficient interdental papilla using injectable albumin platelets rich fibrin

Outcome Measures

Primary Outcomes (1)

  • Distance between contact point and papilla tip (Height of black triangle)

    The distances between the contact point and papilla tip will be measured clinically by a periodontal probe

    6 months

Study Arms (1)

patients whose had deficient interdental papilla

OTHER

treatment of patients whose had deficient interdental papilla using injectable Albumin -platelets rich fibrin

Biological: Injectable albumin platelets rich fibrin

Interventions

Using injectable albumin platelets rich fibrin which is minimally invasive non surgical technique with autogenous , slow degradable and rich in leukocytes and growth factors material .

patients whose had deficient interdental papilla

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients' complaint from poor esthetics and unappealing black triangles in anterior sextant.
  • Patients had well -aligned maxillary teeth, no caries, no proximal restoration, fixed prosthesis, or any orthodontic appliance.
  • Patients had at least one class 1or 2 interdental papilla loss in maxillary or mandibular anterior regions.
  • Patients had at selected sites, distance between contact point and inter proximal bone crest less than 7mm and probing depth less than 4mm.
  • Patients had plaque index and gingival index less than 1.

You may not qualify if:

  • Patient had advanced periodontal problems (advanced bone and soft tissue loss).
  • Patients had a systemic condition affect blood components and healing.
  • Smoker patients.
  • Patients who are pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Dentistry , Cairo University

Giza, Giza Governorate, 12613, Egypt

Location

Faculty of Dentistry Cairo University

Giza, Giza Governorate, 12613, Egypt

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A case series
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Student

Study Record Dates

First Submitted

February 19, 2025

First Posted

February 24, 2025

Study Start

February 18, 2025

Primary Completion

December 30, 2025

Study Completion

April 1, 2026

Last Updated

February 25, 2025

Record last verified: 2025-02

Locations