The Effect Of Hyaluronic Acid And Melatonin With Systemic Administration of Vitamin C On Implant Stability After Immediate Implant in Anterior Region
1 other identifier
interventional
24
0 countries
N/A
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2019
Typical duration for phase_4
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
First Submitted
Initial submission to the registry
January 11, 2019
CompletedFirst Posted
Study publicly available on registry
January 15, 2019
CompletedStudy Start
First participant enrolled
February 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedJanuary 16, 2019
January 1, 2019
3 years
January 11, 2019
January 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
implant stability
implant stability by ostell
6 months
Secondary Outcomes (1)
soft tissue healing
6 months
Study Arms (2)
implant with hyaluronic melatonin vit c
EXPERIMENTALimplant placement with topical application of hyaluronic and melatonin and systemic administration of vitamin C
immediate implant
ACTIVE COMPARATORimmediate implant placement alone without melatonin or hyauronic acid nor vitamin c
Interventions
immediate implant placement with melatonin and hyaluronic acid and systemic administration vitamin C
immediate implant placement without melatonin and hyaluronic acid and systemic administration vitamin C
Eligibility Criteria
You may qualify if:
- Age: 18-60.
- Systemically healthy patients indicated for single or multiple immediate implants in anterior and premolar region.
- Absence of any peri-apical pathosis.
- Patients with intact buccal plate of bone.
- Patients with adequate bone volume for the dental implant procedure.
- Patient consent approval and signing.
You may not qualify if:
- \. Smokers. 2. Systemic disease that may affect the final outcome of the surgical procedure.
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Related Publications (2)
Lee JH, Kim J, Baek HR, Lee KM, Seo JH, Lee HK, Lee AY, Zheng GB, Chang BS, Lee CK. Fabrication of an rhBMP-2 loaded porous beta-TCP microsphere-hyaluronic acid-based powder gel composite and evaluation of implant osseointegration. J Mater Sci Mater Med. 2014 Sep;25(9):2141-51. doi: 10.1007/s10856-014-5250-0. Epub 2014 Jun 14.
PMID: 24928668BACKGROUNDEl-Gammal MY, Salem AS, Anees MM, Tawfik MA. Clinical and Radiographic Evaluation of Immediate Loaded Dental Implants With Local Application of Melatonin: A Preliminary Randomized Controlled Clinical Trial. J Oral Implantol. 2016 Apr;42(2):119-25. doi: 10.1563/aaid-joi-D-14-00277. Epub 2015 Jun 23.
PMID: 26103559BACKGROUND
Study Officials
- STUDY CHAIR
Mona darhous, PHD
Cairo University
- STUDY CHAIR
Mona shoieb, PHD
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- single blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant lecturer
Study Record Dates
First Submitted
January 11, 2019
First Posted
January 15, 2019
Study Start
February 10, 2019
Primary Completion
February 10, 2022
Study Completion
April 30, 2022
Last Updated
January 16, 2019
Record last verified: 2019-01