NCT05403099

Brief Summary

Effect of Topical Application of Hyaluronic Acid on Stability of Immediate Loading Dental Implant in Posterior Maxilla

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
Last Updated

June 3, 2022

Status Verified

May 1, 2022

Enrollment Period

1 year

First QC Date

May 20, 2022

Last Update Submit

June 1, 2022

Conditions

Keywords

Hyaluronic Acid, dental implant

Outcome Measures

Primary Outcomes (5)

  • implant stability

    using radiofrequency analysis

    immediately after surgery

  • implant stability

    using radiofrequency analysis

    one month

  • implant stability

    using radiofrequency analysis

    three months

  • implant stability

    using radiofrequency analysis

    six months

  • bone density

    bone density around the implant is measured in cone beam computed tomography

    three months

Secondary Outcomes (2)

  • propping depth

    six months

  • bleeding inex

    six months

Study Arms (2)

control

ACTIVE COMPARATOR

Each implant was placed into the prepared implant site.

Other: conventional implant placement

Hyaluronic acid

EXPERIMENTAL

Each implant was placed after topical application of HA on its surface

Other: Hyaluronic acid

Interventions

immediate placement of dental implant after topical application of hyaluronic acid on implant surface

Hyaluronic acid

immediate placement of dental implant without application of hyaluronic acid on implant surface

control

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Highly motivated patients with good oral hygiene.
  • Age 18 years or older.
  • Adequate alveolar bone volume at the implant site, at least 6mm in width and 15 mm in height.
  • Free from any parafunctional habits

You may not qualify if:

  • Patients suffering from any systemic or local disease that contraindicate implant placement or surgery.
  • Pregnancy.
  • Smokers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Merna Elhadidi

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Anodontia

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Tooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Twenty implants were inserted in patients seeking for replacement of missed single or multiple posterior maxillary teeth. Patients were divided randomly into two groups. In the control group, ten implants were placed and immediately loaded. While in the study group, ten implants were coated with hyaluronic acid (HA) immediately before placement and immediately loaded. All patients were clinically evaluated at implant placement time, one, three and six months after loading regarding implant stability. Peri-implant pocket depth and modified sulcus bleeding index were evaluated clinically at six months in all patients. Bone density was evaluated radiographically after three months. All clinical and radiographic data were subjected to statistical analysis.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2022

First Posted

June 3, 2022

Study Start

March 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

June 3, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations