Clinical trial NCT06733870: Peri-implant Soft Tissue and Bone Evaluation in Fully Computer Guided Immediate Implants
Official title: Peri-implant Soft Tissue and Bone Evaluation of One Abutment One Time Concept Following Fully Computer Guided Immediate Implants
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Soft Tissue Healing
Keywords: One abutment one time
Full digital workflow
Immediate implant
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Prospective evaluation of perimplant soft tissue and bone response to one abutment one-time concept versus provisional abutment in fully guided single immediate implant placement.

Detailed description: Patient selection:

The study will be conducted on total of 16 patients recruited from the outpatient clinic of Oral Medicine, Periodontology, Oral Diagnosis and Radiology department, Faculty of Dentistry, Ain-Shams University. Sixteen consecutive healthy male/female patients with single non restorable remaining maxillary root from the right second premolar to the left second premolar will be added to the study.

Sample size analysis :

A sample size of 14 (7 in each group) will be sufficient to detect an effect size of approximately 1.75, with a power (1-β error) of 0.8 (80%) using a two-sided hypothesis test, with a significance level (α error) 0.05 for data. G power program version 3.1.9.2 was used for sample size calculation.This was increased to 8 patients in each group to make up for lost follow up cases The procedure will be explained to all patients and an informed consent will be signed before their inclusion in the study.

These patients will be divided randomly into 2 groups:

Group I: will include 8 patients who will undergo guided immediate implant placement and immediate provisionalization with preplanned PMMA provisional restoration on Ti-Base Group II: will include 8 patients who will undergo guided immediate implant placement and immediate loading by using a final CAD/CAM customized abutment and a cemented CAD/CAM fabricated PMMA provisional restoration.

Eligibility criteria: Inclusion Criteria:

* Males and females aged at least 18 years.
* Patients free from any systemic disease as evidenced by health questionnaire - - Single tooth failure of a maxillary anterior region (incisors, canines, and premolars) with neighbouring teeth present and healthy periodontal conditions.
* Intact socket walls evident on cone beam computed tomography and confirmed on the day of extraction.
* Natural teeth present adjacent to the tooth being replaced in addition to a natural counterpart tooth present for esthetics criteria evaluation.
* Adequate bone apical to the tooth to be replaced with a minimum primary stability of 30 Ncm.
* Thick gingival biotype.

Exclusion Criteria:

* Presence of active infection around the failing tooth or adjacent teeth.
* Presence of active periodontal disease and gingival recession in the esthetic area.
* Systemic diseases , pregnancy and smoking.
* Recent orthodontic treatment.
* Bruxism and parafunctional habits .
* Labial plate dehiscence, fenestration, or loss after tooth extraction
* Inability to achieve primary stability after implant placement
* Vulnerable groups: prisoners, mentally retarded, etc

Primary outcomes:
measure: peri-implant soft tissue volumetric change
timeFrame: 4 months
Secondary outcomes:
measure: Esthetic evaluation
timeFrame: 4 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of Dentistry ASU
Study officials:
affiliation: Faculty of dentistry- Ain Shams University
name: Mohamed Bissar, Associate professor
role: STUDY_DIRECTOR
affiliation: Faculty of dentistry- Ain Shams University
name: Ingy Nouh, lecturer
role: STUDY_DIRECTOR
affiliation: Faculty of dentistry- Ain Shams University
name: Hala Kamal, Professor
role: STUDY_DIRECTOR
References: