NCT05746676

Brief Summary

in this study, insulin and hyaluronic acid will be used after open flap debridement in treatment of periodontal defects. outcome will be evaluated clinically and radiographically

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
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2023

Shorter than P25 for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 13, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

February 13, 2023

Last Update Submit

February 25, 2023

Conditions

Periodontal DiseasesPeriodontal Pocket

Keywords

periodontitisinsulinregeneration

Outcome Measures

Primary Outcomes (2)

  • clinical evaluation

    periodontal pocket depth

    6 months

  • radiographic evaluation

    bone gain assessed by cone beam computed tomography

    6 months

Study Arms (2)

group 1

ACTIVE COMPARATOR
Drug: Insulin

group 2

ACTIVE COMPARATOR
Drug: Hyaluronic acid

Interventions

InsulinDRUG

in treatment of periodontal defects

group 1
Hyaluronic acidDRUG

in treatment of periodontal defects

group 2

Eligibility Criteria

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

You may qualify if:

  • patients diagnosed with periodontitis

You may not qualify if:

  • patients with systemic illness that contraindicate periodontal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University, Faculty of Dentistry

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Periodontal DiseasesPeriodontal PocketPeriodontitisInsulin Resistance

Interventions

InsulinHyaluronic Acid

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsGlycosaminoglycansPolysaccharidesCarbohydrates

Central Study Contacts

Naglaa El-Wakeel, Prof.

CONTACT

+2 01001757761naglaelwakeel@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

February 13, 2023

First Posted

February 28, 2023

Study Start

January 12, 2023

Primary Completion

August 1, 2023

Study Completion

October 1, 2023

Last Updated

February 28, 2023

Record last verified: 2023-02

Locations

EG(1)