Clinical trial NCT06916026: Immediate Implant Placement With Deproteinized Bovine Bone vs Deproteinized Bovine Bone With HAM Gel
Official 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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Badly Broken Down Vital Teeth
Keywords: Immediate implant placement
jumping gap
xenograft
Bone healing
Human amniotic membrane
bovine bone graft
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Buccal bone thickness
timeFrame: At Baseline , Six months & 12 months
Secondary outcomes:
measure: Implant stability
timeFrame: at baseline,6 and 12 months
Other outcomes:
Locations:
city: Suez
country: Egypt
facility: faculty of oral and dental medicine , Suez university
Study officials:
References: