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

A

Ain Shams University

Status

Active, not recruiting

Conditions

Badly Broken Down Vital Teeth

Treatments

Procedure: Xenograft mixed with HAM gel.
Procedure: Xenograft

Study type

Interventional

Funder types

Other

Identifiers

NCT06916026
immediate implant placement

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

24 participants in 2 patient groups

Xenograft
Active Comparator group
Description:
Gap distance grafting using xenograft.
Treatment:
Procedure: Xenograft
Xenograft mixed with HAM gel.
Active Comparator group
Description:
Gap distance grafting using xenograft mixed with HAM gel.
Treatment:
Procedure: Xenograft mixed with HAM gel.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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