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

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ClinicalTrials.gov Identifier: NCT03804177
Recruitment Status : Not yet recruiting
First Posted : January 15, 2019
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Nabil Abdelfatiah, Cairo University

Brief Summary:

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 .


Condition or disease Intervention/treatment Phase
Immediate Dental Implant Procedure: immediate implant placement with melatonin hyaluronic acid vit C Procedure: immediate implant placement without melatonin hyaluronic acid vit C Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: it is randomized clinical trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description: single blinded
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : February 10, 2019
Estimated Primary Completion Date : February 10, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

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 Name: 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 Name: early implant placement




Primary Outcome Measures :
  1. implant stability [ Time Frame: 6 months ]
    implant stability by ostell


Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03804177


Contacts
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Contact: ahmed Nasser, Msc 00201094959526 ahmedelsawi8787@gmail.com

Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Mona darhous, PHD Cairo University
Study Chair: Mona shoieb, PHD Cairo University

Publications:
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Responsible Party: Ahmed Nabil Abdelfatiah, assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT03804177    
Other Study ID Numbers: perio25111987
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: i will check with my study chair

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed Nabil Abdelfatiah, Cairo University:
immediate implant
hyaluronic acid
melatonin
vitamin C
Additional relevant MeSH terms:
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Vitamins
Ascorbic Acid
Melatonin
Hyaluronic Acid
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Central Nervous System Depressants
Adjuvants, Immunologic
Immunologic Factors
Viscosupplements