Clinical trial NCT06601400: Xenograft with or Without Erythropoietin in Immediate Dental Implant
Official title: Evaluation of Bone Dimensional Changes After Using Xenograft with or Without Erythropoietin Around Immediate Implants in the Esthetic Zone: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hopeless Teeth
Keywords: dental implant
Erythropoietin
Xenograft
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: * 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.

Primary outcomes:
measure: Buccal bone thickness.
timeFrame: 1 year follow up period
Secondary outcomes:
measure: Crestal bone loss
timeFrame: 1 year follow up period
measure: Soft tissue thickness.
timeFrame: 1 year follow up period
measure: The pink esthetic score (PES)
timeFrame: 1 year follow up period
measure: Success and survival criteria
timeFrame: 1 year follow up period
measure: Bleeding on probing (BOP)
timeFrame: 1 year follow up period
measure: Pain score
timeFrame: 1, 3, and 7 days
measure: Full-mouth plaque score
timeFrame: 1 year follow up period
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of dentistry, Cairo university
Study officials:
affiliation: Professor of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University.
name: Noha ghallab, PHD
role: STUDY_DIRECTOR
affiliation: lecturer of periodontology
name: Manar El Zanaty, PHD
role: STUDY_CHAIR
References:
citation: Fettouh AIA, Ghallab NA, Ghaffar KA, Mina NA, Abdelmalak MS, Abdelrahman AAG, Shemais NM. Bone dimensional changes after flapless immediate implant placement with and without bone grafting: Randomized clinical trial. Clin Implant Dent Relat Res. 2023 Apr;25(2):271-283. doi: 10.1111/cid.13178. Epub 2023 Jan 3.