Clinical and Radiographic Evaluation of the Effect of Hyaluronic Acid Surface Treatment Versus Sandblasted Acid Etched on Stability of Delayed Dental Implant in Posterior Maxilla.

Bone Loss Clinical Trial

Official title:

Clinical and Radiographic Evaluation of the Effect of Hyaluronic Acid Surface Treatment Versus Sandblasted Acid Etched Surface Treatment on Stability of Delayed Dental Implant in Posterior Maxilla. Comparative Randomized Clinical Trial (RCT).

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06033989
• Other study ID #: Shihanah1993
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: September 2023
• Source: Cairo University
• Contact: Shihanah Alkashi, BSc
• Phone: 00966542044424
• Email: Shihanah.yousef[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Clinical and Radiographic Evaluation of the Effect of Hyaluronic Acid Surface Treatment Versus Sandblasted Acid Etched on Stability of Delayed Dental Implant in Posterior Maxilla.

Description:

A dental implant is one of the procedures to restore missing teeth , to achieved the stability for implant success is the direct growth of bone to the implant surface, known as Osseointegration.As a result, bone stability around dental implants is determined by factors that the implantologist may or may not directly influence, such as local bone quality and bone metabolism, as well as systemic factors such as age, systematic chronic diseases and lifestyle (e.g., smoking habits).Treatment-related factors include augmentation material, implant design (macro and micro), surgical procedures, and loading protocols. Therefore , it may be needed for a surface treatment could alter the topography, chemical content, and roughness of the surface and result in various biological reactions. The surface treatment can also increase the area of contact between the implant and the supporting bone . The rationale is evaluate Increasing the implant stability around implants placed by using hyaluronic acid that act to improving the connection between implant and bone .Sandblasting and acid etching is the most commonly used basic method for modifying the surface of dental implants . the sandblasting procedure "roughs up" the outer layer of the implant,creating a surface that is easier for the bone to grip as the implant heals.While hyaluronic acid and its derivatives have a strong chance of osseointegration and mineralization and have been utilized extensively for bone repair.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 1, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients with missing teeth in posterior maxilla.

• Both genders males and females will be included.

• Age from 18-60 years.

Exclusion Criteria:

• General contraindications to implant surgery.

• Subjected to irradiation in the head and neck area less than 1 year before implantation.

• Untreated periodontitis.

• Poor oral hygiene and motivation.

• Uncontrolled diabetes.

• Pregnant or nursing.

• Substance abuse.

• Psychiatric problems or unrealistic expectations.

• Severe bruxism or clenching.

• Immunosuppressed or immunocompromised.

• Treated or under treatment with intravenous amino-bisphosphonates.

• Active infection or severe inflammation in the area intended for implant placement.

• Unable to open mouth sufficiently to accommodate the surgical tooling.

• Patients participating in other studies, if the present protocol could not be properly followed.

Related Conditions & MeSH terms

• Anodontia
• Bone Loss
• Missing Teeth
• Tooth Loss

Intervention

Drug:
• Hyaluronic acid
Delayed dental implant placement after application of surface treatment to enhance Osseointegration and healing .
• sandblasted, and acid-etched
Delayed dental implant placement after application of surface treatment to enhance Osseointegration and healing .

Procedure:
• Delayed dental implant
Surgical procedure of delayed dental implant in posterior maxilla after application of surface treatment to enhance Osseointegration and healing .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (6)

Cervino G, Meto A, Fiorillo L, Odorici A, Meto A, D'Amico C, Oteri G, Cicciu M. Surface Treatment of the Dental Implant with Hyaluronic Acid: An Overview of Recent Data. Int J Environ Res Public Health. 2021 Apr 27;18(9):4670. doi: 10.3390/ijerph18094670. — View Citation

Gupta R, Gupta N, Weber, DDS KK. Dental Implants. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470448/ — View Citation

Massaro C, Rotolo P, De Riccardis F, Milella E, Napoli A, Wieland M, Textor M, Spencer ND, Brunette DM. Comparative investigation of the surface properties of commercial titanium dental implants. Part I: chemical composition. J Mater Sci Mater Med. 2002 Jun;13(6):535-48. doi: 10.1023/a:1015170625506. — View Citation

Meredith N. Assessment of implant stability as a prognostic determinant. Int J Prosthodont. 1998 Sep-Oct;11(5):491-501. — View Citation

Peck MT, Marnewick J, Stephen L. Alveolar ridge preservation using leukocyte and platelet-rich fibrin: a report of a case. Case Rep Dent. 2011;2011:345048. doi: 10.1155/2011/345048. Epub 2011 Jul 3. — View Citation

Velasco-Ortega E, Jimenez-Guerra A, Monsalve-Guil L, Ortiz-Garcia I, Nicolas-Silvente AI, Segura-Egea JJ, Lopez-Lopez J. Long-Term Clinical Outcomes of Treatment with Dental Implants with Acid Etched Surface. Materials (Basel). 2020 Mar 27;13(7):1553. doi: 10.3390/ma13071553. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant stability	It is assessed by using Osstell To determine the stability after intervention scale from 60 to 70 ISQ 60 low stability 70 high stability .	0-3 months
Secondary	soft tissue healing	It is assessed by using gingival index in Clinical examination scale from 0 Normal 1 Mild inflammation 2 Moderate inflammation 3 Severe inflammation .	10 days
Secondary	bone density	It is assessed by using CBCT To determine the density of bone after intervention	3 months