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.

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06033989
Collaborator
(none)
20
2
15

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Hyaluronic acid
  • Drug: sandblasted, and acid-etched
  • Procedure: Delayed dental implant
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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).
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hyaluronic acids

Hyaluronic acid has a huge potential to speed up the healing process and increase implant stability by enhancing bone/implant interaction and new bone formation.

Drug: Hyaluronic acid
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 .

Active Comparator: Sandblasting acid etched

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.

Drug: 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 .

Outcome Measures

Primary Outcome Measures

  1. Implant stability [0-3 months]

    It is assessed by using Osstell To determine the stability after intervention scale from 60 to 70 ISQ 60 low stability 70 high stability .

Secondary Outcome Measures

  1. soft tissue healing [10 days]

    It is assessed by using gingival index in Clinical examination scale from 0 Normal 1 Mild inflammation 2 Moderate inflammation 3 Severe inflammation .

  2. bone density [3 months]

    It is assessed by using CBCT To determine the density of bone after intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Shihanah Yousef Ahmed Alkashi, Master's degree candidate, Cairo University
ClinicalTrials.gov Identifier:
NCT06033989
Other Study ID Numbers:
  • Shihanah1993
First Posted:
Sep 13, 2023
Last Update Posted:
Sep 13, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shihanah Yousef Ahmed Alkashi, Master's degree candidate, Cairo University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2023