Clinical and Radiographic Evaluation of Natural Bovine Bone With Hyaluronic Acid on Osseointegration of Immediate Implant.

NCT07199725 | Completed Phase 2

• 1 other identifier: 544/2022
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

the goal of this study is to evaluate the effective of natural bovine bone with hyaluronic acid on osseointegration of immediate implants in single rooted badly decayed maxillary anterior teeth and premolars. the main question it aims to answer is does natural bovine with hyaluronic acid affects osseointegration of immediate implants. the study compares immediate implants followed by grafting with natural bovine bone with hyaluronic acid to immediate implants without grafting.

Conditions

Dental Implants

Keywords

immediate dental implants; natural bovine bone

Outcome Measures

Primary Outcomes (2)

• Bone density

  using cone beam CT bone density was measured around the implant in housefield units immediately after implant placement and after 6 months.

  baseline (immediately) and 6 months

• implant stability

  using Osstell device, implant stability was measured immediately after implant placement and after 4 months

  Baseline (immediately) and after 4 months

Secondary Outcomes (1)

• Bone width

  Baseline (immediately) and 6 months

Study Arms (2)

control group

ACTIVE COMPARATOR

control group: 8 immediate implants were inserted in 8 fresh extraction sockets without bone grafting.

Combination Product: immediate dental implant

study group

ACTIVE COMPARATOR

study group: 8 immediate implants were inserted in 8 fresh extraction sockets followed by grafting with natural bovine bone substitute material with hyaluronic acid

Combination Product: immediate dental implant, natural bovine bone substitute material

Interventions

immediate dental implant COMBINATION_PRODUCT

control group: 8 teeth were extracted then 8 immediate implants were placed without bone grafting

control group

immediate dental implant, natural bovine bone substitute material COMBINATION_PRODUCT

study group: 8 teeth were extracted then received 8 immediate implants followed by grafting with natural bovine bone substitute material with hyaluronic acid

study group

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• medically free patients, good oral hygiene, no periapical lesions around teeth to be extracted

You may not qualify if:

• patients with bone or soft tissue defects, poor oral hygiene, heavy smoking, bruxism, severe periodontal disease

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University

Ismailia, 41511, Egypt

Location

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Dental Implantation, Endosseous; Dental Implantation; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Dentistry; Prosthodontics

Study Officials

• Mohamed Said professor

  Suez Canal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: This clinical study was conducted on 16 badly decayed single rooted maxillary anterior teeth and premolars that received 16 immediate implants equally randomized divided into 2 groups. control group: 8 implants were inserted in 8 fresh extraction sockets study group: 8 implants were inserted in 8 fresh extraction sockets followed by grafting with natural bovine bone substitute material with hyaluronic acid (act as study group).

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 30, 2025
• Study Start: November 8, 2022
• Primary Completion: March 15, 2023
• Study Completion: May 20, 2023
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: beginning when the data published with no end date

Locations

EG (1)