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

NCT06916026 | Active Not Recruiting DMC

• 1 other identifier: immediate implant placement
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Badly Broken Down Vital Teeth

Keywords

Immediate implant placement; jumping gap; xenograft; Bone healing; Human amniotic membrane; bovine bone graft

Outcome Measures

Primary Outcomes (1)

• Buccal bone thickness

  assessment of the buccal bone thickness using cone beam computed tomography (CBCT) in mm

  At Baseline , Six months & 12 months

Secondary Outcomes (1)

• Implant stability

  at baseline,6 and 12 months

Study Arms (2)

Xenograft

ACTIVE COMPARATOR

Gap distance grafting using xenograft.

Procedure: Xenograft

Xenograft mixed with HAM gel.

ACTIVE COMPARATOR

Gap distance grafting using xenograft mixed with HAM gel.

Procedure: Xenograft mixed with HAM gel.

Interventions

Xenograft PROCEDURE

Gap distance grafting using xenograft

Xenograft

Xenograft mixed with HAM gel. PROCEDURE

Gap distance grafting using xenograft mixed with HAM gel.

Xenograft mixed with HAM gel.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

faculty of oral and dental medicine , Suez university

Suez, Suez Governorate, 12345, Egypt

Location

MeSH Terms

Interventions

Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: blinding of outcome assessors and participants will be achieved as the different outcomes will be assessed for all groups by assessors other than the researchers doing the procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: April 8, 2025
• Study Start: January 7, 2025
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-01

Locations

EG (1)