The Effect Of Hyaluronic Acid And Melatonin With Systemic Administration of Vitamin C On Implant Stability After Immediate Implant in Anterior Region

January 15, 2019 updated by: Ahmed Nabil Abdelfatiah, Cairo University

The Effect Of Hyaluronic Acid And Melatonin With Systemic Administration of Vitamin C On Implant Stability After Immediate Implant Placement in Anterior and Premolar Region in Systemically Healthy Patients

The concept of immediate implant placement at the time of tooth extraction was first introduced by Schulte et al. on animal studies. Since then, many follow-up studies examining different variables have supported the concept of immediate implant placement. pioneered a major contribution to immediate implant placement in human studies which recommended the insertion of an implant into a fresh extraction socket.

They advocated immediate implant placement primarily to reduce the number of surgical interventions needed to perform an implant-supported rehabilitation and shorten the treatment time.

Placement of implants immediately into extraction sites allow the surgeon to idealize the position of the implant appropriately with a better rehabilitation of the normal contour to the facial aspect of the final restoration.

Immediate implant placement in fresh extraction sockets was reported to reduce alveolar bone resorption. Better esthetic outcomes were achieved including the prosthetic crown length in harmony with the adjacent teeth, natural scalloping and easier distinct papillae to achieve and maximum soft tissue support.

Hyaluronic acid is a glycosaminoglycan, this unique molecule is implicated In a variety of biological functions including structural integrity, and the regulation of embryologic development. It is described as a natural organic substance, with physiological therapy activity, main component of the extracellular matrix of many tissues such as the skin, synovial joints and periodontal tissues .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age: 18-60.
  2. Systemically healthy patients indicated for single or multiple immediate implants in anterior and premolar region.
  3. Absence of any peri-apical pathosis.
  4. Patients with intact buccal plate of bone.
  5. Patients with adequate bone volume for the dental implant procedure.
  6. Patient consent approval and signing.

Exclusion Criteria:

  • 1. Smokers. 2. Systemic disease that may affect the final outcome of the surgical procedure.

    3. No or poor patient's compliance. 4. Patients with psychological problems. 5. Pathology at the site of intervention. 6. Pregnant patients. 7. Patients refuse to sign an informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: implant with hyaluronic melatonin vit c
implant placement with topical application of hyaluronic and melatonin and systemic administration of vitamin C
Procedure: immediate implant placement with melatonin hyaluronic acid vit C
immediate implant placement with melatonin and hyaluronic acid and systemic administration vitamin C
Other Names:
  • early implant placement
ACTIVE_COMPARATOR: immediate implant
immediate implant placement alone without melatonin or hyauronic acid nor vitamin c
Procedure: immediate implant placement without melatonin hyaluronic acid vit C
immediate implant placement without melatonin and hyaluronic acid and systemic administration vitamin C
Other Names:
  • early implant placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
implant stability
Time Frame: 6 months
implant stability by ostell
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
soft tissue healing
Time Frame: 6 months
soft tissue healing by likert scale (0 indicate complete soft tissue Closure (no line of fibrin) , 1 indicate complete closure (thin line of fibrin) , 2 indcate complete closure (fibrin) , 3 indicate in complete closure (dehiscence ) , 4 indicate incomplete closure (necrosis)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Mona shoieb, PHD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 10, 2019

Primary Completion (ANTICIPATED)

February 10, 2022

Study Completion (ANTICIPATED)

April 30, 2022

Study Registration Dates

First Submitted

January 11, 2019

First Submitted That Met QC Criteria

January 11, 2019

First Posted (ACTUAL)

January 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 16, 2019

Last Update Submitted That Met QC Criteria

January 15, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • perio25111987

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

i will check with my study chair

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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