Immediate Implant Placement With Deproteinized Bovine Bone vs Deproteinized Bovine Bone With HAM Gel

April 4, 2025 updated by: Ain Shams University

A Comparison of Immediate Implant Placement With Deproteinized Bovine Bone vs Deproteinized Bovine Bone With HAM Gel as Space Filling Material: A Randomized Controlled Trial.

Statement of the problem: Immediate implant placement is faced with several problems. One of the most important is the jumping gap present after implant placement and whether it needs to be augmented or not.

Aim: The aim of this study is to compare the effect of xenograft to xenograft mixed with HAM gel for grafting of the jumping gap in immediate implant placement in the molar region.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Aim: The aim of this study is to compare the effect of xenograft to xenograft mixed with HAM gel for grafting of the jumping gap in immediate implant placement in the molar region.

Materials and Methods: This parallel arm, randomized controlled clinical trial will involve systemically free patients with remaining roots or badly decayed teeth in the posterior region requiring implant placement. They will be randomly allocated to two equal groups. Group A (control group, n=12) will receive immediate implants (grafting with xenograft), and group B (test group, n=12) will receive immediate implants (grafting with xenograft& HAM). After implant placement, buccal bone thickness (1ry outcome), bone density (2nd outcome) and implant stability will be assessed (2nd outcome). The parameters will be assessed at baseline, 6 and 12 months. Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post surgically. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Follow-up will be performed to assess the parameters and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Suez, Egypt, 12345
        • faculty of oral and dental medicine , Suez university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients at least 18 years old, with non-restorable first and second molars indicated for immediate implant placement in both arches.
  • Patient who are medically free patients (American Society of Anesthesiologists I; ASA I)
  • Minimum remaining alveolar height of four to six millimeters distance from the apex of the socket to the floor of maxillary sinus for maxillary teeth and minimum remaining alveolar height of six millimeters distance from the apex of the socket to the inferior alveolar nerve for mandibular teeth.
  • Minimum alveolar Bucco-palatal dimension of 7 mm.

Exclusion Criteria:

  • Patients with known systemic diseases which can affect normal bone formation or blood coagulation.
  • Patients who are smokers.
  • Presence of signs of active infection or pus formation.
  • Absence or loss of buccal wall prior to implant placement.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Xenograft
Gap distance grafting using xenograft.
Procedure: Xenograft
Gap distance grafting using xenograft
Active Comparator: Xenograft mixed with HAM gel.
Gap distance grafting using xenograft mixed with HAM gel.
Procedure: Xenograft mixed with HAM gel.
Gap distance grafting using xenograft mixed with HAM gel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Buccal bone thickness
Time Frame: At Baseline , Six months & 12 months
assessment of the buccal bone thickness using cone beam computed tomography (CBCT) in mm
At Baseline , Six months & 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant stability
Time Frame: at baseline,6 and 12 months
using Ostell
at baseline,6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2025

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

April 4, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 4, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • immediate implant placement

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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