Clinical trial NCT05360693: Radiographic Evaluation of The Labial Bone Dimensional Changes After Immediate Implant
Official title: Evaluation of Horizontal and Vertical Labial Bone Dimensional Changes After Flapless Immediate Implant Placement With and Without Bone Grafting: A 1-year Cone-beam Computed Tomography Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immediate Implants
Esthetic Zone
Labial Bone Dimensional Changes
Without Labial Bone Grafting
With Labial Grafting
Thin Labial Plate of Bone Pre-extraction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: For the dimension of the peri-implant buccal gap, a controversy is present whether complete bone formation labial to the implant. Therefore, leaving the blood clot in the large socket around implants without augmentation is questionable to result in complete bone fill and would not affect the buccal contour collapse. The aim of this clinical trial was to evaluate the labial bone dimensional changes after immediate implant placement in the esthetic zone with \& without bone grafting inside the socket by using CBCT superimposition (Fusion) scans.


Eligibility criteria: inclusion criteria:

1. adult (\>20 years) with non-restorable maxillary teeth in the esthetic zone,
2. thick gingival phenotype,
3. intact but thin labial plate of bone (≤1mm)
4. intact palatal bone extending at least 6mm apically,
5. sufficient apical bone to attain implant primary stability (a minimum of 35 Ncm insertion torque)
6. labio-palatal socket dimension measured from the CBCT axial cut at mid-crestal part ≥5mm.
7. patients agreed to sign a written informed consent.

Exclusion criteria:

1. smokers,
2. pregnant women,
3. patients with systemic disease,
4. patients with parafunctional habits such as bruxism or clenching,
5. infected socket,
6. periapical pathosis
7. history of radiotherapy or chemotherapy within the past 2 years.

Primary outcomes:
measure: Amount of bone labial to the implant
timeFrame: 1 year
measure: Horizontal labio-palatal bone width
timeFrame: 1 year
measure: horizontal labio-palatal bone collapse
timeFrame: 1 year
measure: vertical bone dimensional changes
timeFrame: 1 year
Secondary outcomes:
measure: gingival index
timeFrame: 1 year
measure: Implant failure
timeFrame: 1 year
measure: Plaque Index
timeFrame: 1 year
measure: Postoperative Pain
timeFrame: 1 day, 3 days, 7 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: International Dental Continuing Education
state: Maadi
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
state: Manial
Study officials:
affiliation: Professor of Oral Medicine & Periodontology
name: Noha A Ghallab, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Misr International University
name: Ahmed I Abou- El-Fettouh, MSc
role: STUDY_DIRECTOR
affiliation: Misr International University
name: Abdelrahman Zohny, BDs
role: PRINCIPAL_INVESTIGATOR
affiliation: Misr International University
name: Nael M Adel, BDs
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Periodontology, Ain Shams University
name: Khaled Abdelghaffar, PhD
role: STUDY_CHAIR
affiliation: Misr International University
name: Mariam S Abdelmalak, BDs
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of Oral Medicine & Periodontology, Cairo University
name: Nesma M Shemais, PhD
role: PRINCIPAL_INVESTIGATOR
References: