NCT04843826

Brief Summary

This case series trial aims to evaluate the effect of a modified pedicle subepithelial connective tissue graft in creating anatomical papilla around one-stage delayed implant in the esthetic zone to establish better esthetics.

Trial Health

43
At Risk

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 not_applicable

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

April 14, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 14, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2021

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2020

Enrollment Period

1 month

First QC Date

April 4, 2021

Last Update Submit

April 11, 2021

Conditions

Papilla Reconstruction

Outcome Measures

Primary Outcomes (1)

  • papilla height

    Periodontal probe and reference line

    3 month

Study Arms (1)

delayed implant

EXPERIMENTAL

1. Patients 18 years or older. 2. Periodontally and systemically healthy. 3. Sufficient bone width and height for implant placement 4. Adequate mesiodistal width and inter-arch space for placement of a delayed implant. 5. Full mouth plaque index less than 15% (Bentley and Disney, 1995) 6. cooperative patients who will comply to follow up visits

Procedure: papilla reconstruction

Interventions

papilla reconstructionPROCEDURE

subepithelial connective tissue graft for interdental papillary reconstruction around delayed

Also known as: create papilla around delayed implant
delayed implant

Eligibility Criteria

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

You may not qualify if:

  • Pregnant females.
  • Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, et al., 2009)
  • Handicapped and mentally retarded patients.
  • Patients undergoing radiotherapy.
  • Presence of systemic disease that would affect wound healing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Faculty of Dentistry

Cairo, Manial, 11865, Egypt

RECRUITING

Central Study Contacts

Ahmed Sadek Mohamed, master

CONTACT

23634965ahmed.sadek@dentistry.edu.cu.eg

weam Ahmed el batawy, PHD

CONTACT

23634965weamelbatawy@dentistry.edu.cu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Case Series trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
teacher assistance

Study Record Dates

First Submitted

April 4, 2021

First Posted

April 14, 2021

Study Start

April 14, 2020

Primary Completion

May 20, 2020

Study Completion

September 14, 2021

Last Updated

April 14, 2021

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)