Faculty of dentistry, Cairo university
Giza, Egypt
Location contact
Cairo University
CONTACT
(+202)23634965
kholoud Sobhy Eldeeb, Master degree holder
CONTACT
Not Yet Recruiting
NCT Number: NCT06601400
Xenograft with or Without Erythropoietin in Immediate Dental Implant
The aim of this study is to evaluate changes in buccal bone thickness after immediate implant placement with xenograft mixed with erythropoietin in the anterior maxilla with a thin buccal bone
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
PICO:
Population: Patients with non-restorable tooth in anterior maxilla with thin buccal bone (less than 1mm) Intervention: Immediate implant placement with Xenograft mixed with Erythropoietin.
Control: Immediate implant placement with Xenograft alone.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
- Inclusion criteria
- Adult (≥18 years) with non-restorable maxillary teeth in the esthetic zone (upper right second premolar to upper left second premolar).
- Intact with thin labial plate of bone (≤1mm).
- The recipient site of the implant should be free from any pathological conditions.
- Patients who are cooperative, motivated and hygiene conscious.
- Appropriate crown height space to maintain favorable crown : implant ratio
- Exclusion criteria
- Systemic conditions/diseases that contraindicate surgery.
- Patients who have any habits that might jeopardize the osseointegration process, such as current smokers.
- Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching.
- Patients with periodontal disease.
- Alcohol or drug abuse.
- Pregnant and lactating women.
Treatment and study plan
Erythropoietin (EPO) with xenograft
Combination ProductAfter atraumatic extraction of the non-restorable tooth, Implant will be placed palatal and apical to osteotomy with at least 2mm gap junction between implant and buccal bone which will be grafted with xenograft and erythropoietin.
Xenograft alone
OtherAfter atraumatic extraction of the non-restorable tooth, implant will be placed palatal and apical to osteotomy with at least 2mm gap junction between implant and buccal bone which will be grafted with xenograft alone.
Primary outcomes
-
Buccal bone thickness.
Time frame: 1 year follow up period
by Cone Beam Computed Tomography (CBCT) in mm
Secondary outcomes
-
Crestal bone loss
Time frame: 1 year follow up period
will be measured by Cone Beam Computed Tomography (CBCT) in mm
-
Soft tissue thickness.
Time frame: 1 year follow up period
will be measured by Endodontic spreader with rubber stopper in mm
-
The pink esthetic score (PES)
Time frame: 1 year follow up period
by taking photographs
-
Success and survival criteria
Time frame: 1 year follow up period
the absence of mobility, the absence of acute or chronic peri-implant infection, the absence of radiolucency around the implant, without pocket probing depth (PPD) ≧ 5 mm, and without vertical bone loss ≧ 1.5 mm in the first year. The cases will be defined as failure if it can't reach any one of the success criteria
-
Bleeding on probing (BOP)
Time frame: 1 year follow up period
According to presence (yes) or absence (No) of bleeding on probing
-
Pain score
Time frame: 1, 3, and 7 days
by using Visual analogue scale from (0-10)
-
Full-mouth plaque score
Time frame: 1 year follow up period
According to presence (yes) or absence(No) of plaque
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Cairo University
Other
Registry information
Official study title
Evaluation of Bone Dimensional Changes After Using Xenograft with or Without Erythropoietin Around Immediate Implants in the Esthetic Zone: a Randomized Clinical Trial
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- Sep 19, 2024
- Registry last updated
- Sep 19, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.