Clinical trial NCT06554444: Assessment of Early Healing Period of Dental Implants
Official title: Assessment of Volumetric Changes During the Early Healing Period of Dental Implant Treatment: Clinical, Radiographic, and Digital Evaluation
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Dental Implant
Osseointegration
Biological Width
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Dental implant placement in the posterior mandible
Primary purpose: SCREENING

Brief summary: This prospective cohort study aimed to evaluate, clinically, radiographically, and digitally, the volumetric changes occurring during the early healing period after implant treatment in patients with tooth loss in the posterior regions of the jaws, focusing on the processes of osseointegration and biological width formation.


Eligibility criteria: Inclusion Criteria:

* Over the age of 18
* Systemically healthy
* Need for implant treatment in unilaterally edentulous posterior mandible
* Sufficient interocclusal space for implant and restoration placement
* At least four months passed since tooth extraction
* Alveolar bone height adequate for implant placement, with a minimum width of 6 mm, and without risking anatomical structures
* Plaque and bleeding scores of less than 15% in the entire mouth
* Presence of opposing teeth in occlusion
* Written informed consent obtained, including permission for the use of data for research purposes

Exclusion Criteria:

* Poor oral hygiene
* Uncontrolled periodontal disease
* Pregnancy or lactation at any stage of the study
* Uncontrolled diabetes
* Patients with suppressed immune systems
* History of radiotherapy to the head and neck region
* Diseases or medications affecting bone metabolism
* Smoking more than 10 cigarettes per day
* Bone augmentation performed before or concurrently with the implant
* Failure to achieve primary stability with the implant

Primary outcomes:
measure: Linear changes in the tissue
timeFrame: Preoperative and postoperative 2nd, 4th, and 12th months
Secondary outcomes:
measure: Keratinized mucosa width (from the edentulous ridge)
timeFrame: Preoperative and postoperative 2nd month
measure: Keratinized mucosa width (from the gingival margin of the dental implant-supported prosthesis)
timeFrame: Postoperative 4th and 12th months
measure: Mucosal thickness (from the edentulous ridge)
timeFrame: Preoperative and postoperative 2nd month
measure: Mucosal thickness (from the facial aspect of the edentulous ridge)
timeFrame: Preoperative and postoperative 2nd month
measure: Mucosal thickness (from 3 mm apical to the gingival margin of the implant-supported prosthesis)
timeFrame: Postoperative 4th and 12th months
measure: Peri-implant pocket depth
timeFrame: Postoperative 4th and 12th months
measure: Modified plaque index
timeFrame: Postoperative 4th and 12th months
measure: Modified bleeding index
timeFrame: Postoperative 4th and 12th months
measure: Marginal bone level
timeFrame: Preoperative and postoperative 2nd, 4th, and 12th months
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Sciences University
Study officials:
References:
citation: Tavelli L, Barootchi S, Vera Rodriguez M, Mancini L, Meneghetti PC, Mendonca G, Wang HL. Early soft tissue changes following implant placement with or without soft tissue augmentation using a xenogeneic cross-link collagen scaffold: A volumetric comparative study. J Esthet Restor Dent. 2022 Jan;34(1):181-187. doi: 10.1111/jerd.12856. Epub 2021 Dec 22.