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

Phase 4

• Conditions: Immediate Dental Implant
• Interventions: Procedure: immediate implant placement with melatonin hyaluronic acid vit C; Procedure: immediate implant placement without melatonin hyaluronic acid vit C

• Registration Number: NCT03804177
• Lead Sponsor: 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 .

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-11
• Study First Submitted QC: 2019-01-11
• Study First Posted: 2019-01-15
• Last Update Submitted: 2019-01-15
• Last Update Posted: 2019-01-16
• Study Start: 2019-02-10
• Primary Completion: 2022-02-10
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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.

  2. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
implant with hyaluronic melatonin vit c	immediate implant placement with melatonin hyaluronic acid vit C	implant placement with topical application of hyaluronic and melatonin and systemic administration of vitamin C
immediate implant	immediate implant placement without melatonin hyaluronic acid vit C	immediate implant placement alone without melatonin or hyauronic acid nor vitamin c

Primary Outcome Measures

Name	Time	Method
implant stability	6 months	implant stability by ostell

Secondary Outcome Measures

Name	Time	Method
soft tissue healing	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)