Clinical trial NCT05632172: Buccal and Palatal Bone Thickness and Marginal Bone Changes Implants
Official title: Influence of Buccal and Palatal Bone Thickness on Post-surgical Marginal Bone Changes Around Implants Placed in Posterior Maxilla
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Implant; Complications
Keywords: implant
peri-implant bone remodeling
posterior maxilla
bone thickness
Lead sponsor: International Piezosurgery Academy
Sponsor class: OTHER
Collaborators: name: University of Trieste
name: University of Messina
name: University of Campania Luigi Vanvitelli
First posted: 2022-11-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any patient presenting a single edentulism in the upper premolar area and requiring implant-prosthetic rehabilitation was eligible for this study. Furthermore, patients have to comply with the following inclusion and exclusion criteria.

Brief summary: The primary outcome of the study was the vertical variation of peri-implant buccal and palatal bone level from implant placement (T0) to uncovering stage (3 months later - T1)

Detailed description: despite various recommendations, there is insufficient evidence to set a threshold for minimal buccal bone thickness necessary to ensure peri-implant marginal bone stability and optimal aesthetic outcomes.

Therefore, the aim of the present multi-centre prospective study was to investigate the influence of buccal and palatal bone thickness at the time of implant placement on peri-implant bone remodeling during the submerged healing period, with a strict control of possible confounding factors.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years;
* no smokers;
* no history of periodontal disease;
* healed bone crest (at least six months after tooth extraction);
* crestal bone height ≥8 mm;
* crestal bone with a minimum bucco-palatal width of 6 mm with no concomitant or previous bone augmentation procedures.

Exclusion Criteria:

* absolute contraindications to implant surgery
* immunological or genetic disorders;
* uncontrolled diabetes (HBA1c \> 7.5%);
* present or past treatment with anti resorptive drugs;
* oncologic patients;
* history of head or neck radiotherapy;
* alcohol or drugs abuse;
* final insertion torque \> 50 Ncm.

Primary outcomes:
measure: peri-implant bone changes in width buccal
timeFrame: three months after surgery
measure: peri-implant bone changes in width palatal
timeFrame: three months after surgery
measure: peri-implant bone changes in height buccal
timeFrame: three months after surgery
measure: peri-implant bone changes in height palatal
timeFrame: three months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Cassano allo Ionio
country: Italy
facility: Hesire
state: CS
city: Verona
country: Italy
facility: Studio B
state: VR
Study officials:
affiliation: Piezoelectric Surgery Academy
name: Claudio Stacchi, Dr
role: STUDY_CHAIR
References:
citation: Merheb J, Quirynen M, Teughels W. Critical buccal bone dimensions along implants. Periodontol 2000. 2014 Oct;66(1):97-105. doi: 10.1111/prd.12042.