NCT03701191

Brief Summary

Perioteum in the recession defect site will be used as an autogenous graft after raising a flap and the results will be compared with another group which will be treated by the gold standard ( coronally advanced flap with subepithelial connective tissue graft).

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
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

October 7, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 25, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

1 month

First QC Date

October 7, 2018

Last Update Submit

January 9, 2020

Conditions

Keywords

gingival recession, periosteum, autogenous graft

Outcome Measures

Primary Outcomes (1)

  • Post-operative discomfort

    Numerical using Visual analogue scale (VAS) Questionnaire

    3 weeks

Secondary Outcomes (4)

  • Amount of root coverage

    3 months and 6 months

  • Probing depth

    3 months and 6 months

  • esthetics

    6 months

  • patient's satisfaction

    6 months

Study Arms (2)

Grpup A (Test group)

EXPERIMENTAL

Inverted periosteal pedicle flap will be carried out

Procedure: Inverted periosteal pedicle flap

Group B (Control group)

ACTIVE COMPARATOR

Coronally advanced flap with subepithelial connective tissue graft

Procedure: Inverted periosteal pedicle flap

Interventions

The periosteum will be used as an autogenous graft after raising a partial thickness flap in group A

Group B (Control group)Grpup A (Test group)

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gender: Male and Female
  • Age: \>20 years
  • Have RT1 and RT2 gingival recession

You may not qualify if:

  • Medically compromised
  • History of certain medications
  • Pregnant females
  • Periapical involvement in selected teeth
  • History of periodontal surgery involving experimental teeth
  • If the problem was due to orthodontic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university, Faclty of dentistry

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Central Study Contacts

Marwa El Sayed, Ass. lec.

CONTACT

Ahmed Re da Abd EL Rahman, Ass. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Two outcome assessors will be chosen: one will be a periodontist but not included within the research; and the other will be a non-periodontist. The outcome assessors will be blinded; they will not be informed by the type of intervention to be assessed.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Included participants will be: 1. Gender: Male and Female 2. Age: \>20 years 3. Have RT1 and RT2 gingival recession Exclusion criteria: 1. Medically compromised 2. History of certain medications 3. Pregnant females 4. Periapical involvement in selected teeth 5. History of periodontal surgery involving experimental teeth 6. If the problem was due to orthodontic treatment
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

October 7, 2018

First Posted

October 9, 2018

Study Start

January 25, 2020

Primary Completion

February 28, 2020

Study Completion

August 28, 2020

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will share

publishing in an international journal

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
1 year

Locations