NCT05334745

Brief Summary

The aim of the study is to evaluate the effect of application of Alvogyl versus hyaluronic acid in decreasing postoperative pain and promoting healing in the palatal wound following the free gingival graft procedure

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
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2021

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

December 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

April 7, 2022

Last Update Submit

April 18, 2022

Conditions

Wound Healing

Outcome Measures

Primary Outcomes (1)

  • postoperative pain

    Pain through one week using the visual analogue scale (VAS)

    7th days

Secondary Outcomes (1)

  • Wound healing

    7th, 14th, 21st and 30th days.

Study Arms (2)

application of Alvogyl in the palatal wound with stent

EXPERIMENTAL
Other: Alvogyl

application of 0.2% Hyaluronic acid is placed in the palatal wound with stent .

OTHER
Other: Alvogyl

Interventions

AlvogylOTHER

application of Alvogyl in the palatal wound with stent versus hyaluronic acid application

Also known as: Hyaluronic acid
application of 0.2% Hyaluronic acid is placed in the palatal wound with stent .application of Alvogyl in the palatal wound with stent

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with mucogingival defects scheduled for free gingival graft
  • Age from 18 years up to 60
  • Medically healthy patient

You may not qualify if:

  • Systemic diseases that may be a contraindication for any surgeries.
  • Loss of maxillary premolars and molars.
  • Pregnancy or lactation
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Egypt

Cairo, 11865, Egypt

RECRUITING

MeSH Terms

Interventions

butyl aminobenzoate, eugenol, iodoform, spearmint oil drug combinationsHyaluronic Acid

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Central Study Contacts

mohy eldin aboelazayem, TA

CONTACT

+201005007001mohy.aboelazayem@dentistry.cu.edu.eg

shaimaa Nasr, PHD

CONTACT

+01272789994dr.shaimaanasr@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 7, 2022

First Posted

April 19, 2022

Study Start

December 1, 2021

Primary Completion

December 1, 2022

Study Completion

January 1, 2023

Last Updated

April 19, 2022

Record last verified: 2022-04

Locations

EG(1)