Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06207617 |
| Other study ID # |
IDCE.N9 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2024 |
| Est. completion date |
August 1, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Misr International University |
| Contact |
Nourhan Gamal |
| Phone |
01064249441 |
| Email |
nourhannegamal259[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Statement of problem: The majority of studies on immediate implant placement are related to
the maxillary esthetic zone. Literature concerning Immediate implant placement in the
posterior region is scarce. Furthermore, there is paucity of evidence on alveolar bone
dimensional changes following immediate implant placement in fresh extraction sockets of
posterior teeth. Adding to that, negligible evidence is known about the soft tissue
alterations which take place during modeling and remodeling phases of socket healing process;
regarding the molar sites. Nevertheless, Immediate installation into a molar socket raises an
extra challenge for the clinicians, because of the different anatomical features of the
extraction sockets compared to that of the single-rooted teeth in the anterior zone. In
addition to, implant positioning difficulties; due to the amount of the residual
inter-radicular bone after extraction. Aim of the study: To assess the bucco-lingual ridge
collapse after immediate implant placement in lower 1st molar sites either with customized
healing abutment only; or with xenogeneic bone graft and customized healing abutment.
Materials and methods: The current study will include 28 non-restorable lower 1st molar teeth
indicated for extraction in the posterior area. Patients will randomly be assigned into two
equal groups: the test group; Immediate implant placement + customized healing abutment group
and the control group; Immediate implant placement +bone graft+ customized healing abutment
group. The presented trial will investigate the following outcomes: bucco-lingual ridge
collapse as the primary outcome, together with mid-facial recession, total volume gain/loss,
buccal soft tissue contour, bucco-lingual bone width, and vertical bone changes as the
secondary outcomes after 12 months
Description:
After administration of local anesthesia, flapless atraumatic extraction will be performed
using peristomes inserted along the root surface, apical pressure and rocking motion will be
applied circumferentially to cut the periodontal ligaments. After initial luxation using
Harpoon luxators, bayonet forceps will be used to deliver the tooth out of the socket. Often
separation of the mesial and distal roots will be employed, to facilitate tooth delivery
without impinging the soft and hard tissue architecture. Socket debridement will be done
using socket curette and saline irrigation, to make sure the socket is thoroughly clean with
no remnants of any periapical pathosis.
Immediate implant placement + customized healing abutment (Test group): After atraumatic
extraction, flapless immediate implant of a suitable size will be placed using sequential
drills of the Straumann implant system for osteotomy preparation. According to the
prosthetically driven planned position, implant will be placed. Primary stability of the
implant will be measured by rotational insertion torque, to be more than or equal 30 Ncm. All
patients will receive an immediate anatomical customized healing abutment fabricated by
adding flowable composite to the temporary cylindrical abutment mimicking the shape of the
socket at the marginal gingiva, then it will be screwed to the implant.
Immediate implant placement + xenogeneic bone graft material + customized healing abutment
(Control) After atraumatic extraction, immediate implant will be placed as mentioned-above,
then particulate xenogeneic bone graft will be packed into the gap between the implant and
the buccal plate mesially and distally. bone grafting will be up to the level of the buccal
bone crest, followed by screwing the customized healing abutment.
Objectives:
- To compare Bucco-lingual ridge dimension between the two groups at baseline and one-year
postoperative.
- To compare the volumetric changes in the labial soft tissue contour between the two
groups assessed in mm and mm3.
- To assess and compare the Bucco-palatal bone width, and vertical bone changes in mm
using cone beam computed tomography (CBCT) preoperative and at 12 Months.
- To evaluate mid facial gingival recession assessed in mm by the volumetric analysis.
- To assess peri-implant soft tissue parameters by plaque and bleeding indices.
- To assess any surgical or prosthetic complications.
- To assess Implant Failure and Implant Survival Rate
