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

NCT ID: NCT06916026

Last Updated: 2025-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-07

Study Completion Date

2025-08-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Badly Broken Down Vital Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Xenograft

Gap distance grafting using xenograft.

Group Type ACTIVE_COMPARATOR

Xenograft

Intervention Type PROCEDURE

Gap distance grafting using xenograft

Xenograft mixed with HAM gel.

Gap distance grafting using xenograft mixed with HAM gel.

Group Type ACTIVE_COMPARATOR

Xenograft mixed with HAM gel.

Intervention Type PROCEDURE

Gap distance grafting using xenograft mixed with HAM gel.

Interventions

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Xenograft

Gap distance grafting using xenograft

Intervention Type PROCEDURE

Xenograft mixed with HAM gel.

Gap distance grafting using xenograft mixed with HAM gel.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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faculty of oral and dental medicine , Suez university

Suez, Suez Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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immediate implant placement

Identifier Type: -

Identifier Source: org_study_id

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