Clinical trial NCT03804177: The Effect Of Hyaluronic Acid And Melatonin With Systemic Administration of Vitamin C On Implant Stability After Immediate Implant in Anterior Region
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Immediate Dental Implant
Keywords: immediate implant
hyaluronic acid
melatonin
vitamin C
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: it is randomized clinical trial
Primary purpose: TREATMENT

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 .


Eligibility 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.

Primary outcomes:
measure: implant stability
timeFrame: 6 months
Secondary outcomes:
measure: soft tissue healing
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Mona darhous, PHD
role: STUDY_CHAIR
affiliation: Cairo University
name: Mona shoieb, PHD
role: STUDY_CHAIR
References:
citation: 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.
citation: El-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.