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

Immediate Dental Implant Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03804177
• Other study ID #: perio25111987
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 10, 2019
• Est. completion date: April 30, 2022

Study information

• Verified date: January 2019
• Source: Cairo University
• Contact: ahmed Nasser, Msc
• Phone: 00201094959526
• Email: ahmedelsawi8787[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: April 30, 2022
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Immediate Dental Implant

Intervention

Procedure:
• immediate implant placement with melatonin hyaluronic acid vit C
immediate implant placement with melatonin and hyaluronic acid and systemic administration vitamin C
• immediate implant placement without melatonin hyaluronic acid vit C
immediate implant placement without melatonin and hyaluronic acid and systemic administration vitamin C

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (2)

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. — View 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 ß-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	implant stability	implant stability by ostell	6 months
Secondary	soft tissue healing	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