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NCT Number: NCT06916026

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of oral and dental medicine , Suez university

Suez, Suez Governorate, 12345, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

xenograft

Procedure

Gap distance grafting using xenograft

Xenograft mixed with HAM gel.

Procedure

Gap distance grafting using xenograft mixed with HAM gel.

Primary outcomes

  1. 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

Secondary outcomes

  1. Implant stability

    Time frame: at baseline,6 and 12 months

    using Ostell

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2025
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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