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

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.

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06916026
Enrollment
24
Registered
2025-04-08
Start date
2025-01-07
Completion date
2025-08-01
Last updated
2025-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Badly Broken Down Vital Teeth

Keywords

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

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.

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.

Interventions

PROCEDUREXenograft

Gap distance grafting using xenograft

PROCEDUREXenograft mixed with HAM gel.

Gap distance grafting using xenograft mixed with HAM gel.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Buccal bone thicknessAt Baseline , Six months & 12 monthsassessment of the buccal bone thickness using cone beam computed tomography (CBCT) in mm

Secondary

MeasureTime frameDescription
Implant stabilityat baseline,6 and 12 monthsusing Ostell

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026