Clinical trial NCT05754970: Clinical, Prospective, Non-profit, Non-pharmacological Study on Geass Healing Abutment: Microbiological, Histological, and Immuno-histochemical Evaluation.
Official title: Clinical, Prospective, Non-profit, Non-pharmacological Study on Geass Healing Abutment: Microbiological, Histological, and Immuno-histochemical Evaluation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant Failed
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: To prevent allocation bias among patients, each healing abutment was designed with two surfaces that alternated between laser-treated/machined and ma-chined/laser-treated. The experimental healing abutment was removed after 30 ± 7 days, which coincided with the soft tissue biopsy.
Primary purpose: TREATMENT

Brief summary: The health of peri-implant soft tissues is important for the long-term success rate of dental implants and the surface topography is pivotal in influencing it. Thus, the aim of this study was to evaluate, in human patients, the inflammatory mucosal microenvironment in the tissue surrounding a new, nanoscale, laser-treated healing abutment characterized by engineered nanopores versus a standard machined-surface.

The prospective clinical study will evaluate the effect of the presence of a laser-etched surface in the coronal portion of healing stumps in forming the coronal seal and reducing the accumulation of bacterial plaque around it. The screws will serve as their own control group since they have both a laser-etched and a smooth portion.

Primary objective:

To evaluate the adhesion of fibroblastic cells from the peri-implant mucosa on the surface of the healing stump through scanning electron microscope analysis, expressed in terms of the area covered by the cells.

Secondary objectives:

To evaluate the amount of bacterial adhesion around healing stumps with a laser-etched and smooth altered surface through scanning electron microscope analysis, expressed in terms of the area covered by the cells.

To evaluate the presence of hemidesmosomal structures through the expression of α-6 and β-4 integrins.

To evaluate bacterial adhesion on healing screws. To evaluate the healing of peri-implant soft tissues through clinical indices, such as Plaque Index and Gingival Index.

The healing period was 12 ± 4 weeks (T1) before the second surgical procedure, during which all healing abutments were placed. To prevent allocation bias among patients, each healing abutment was designed with two surfaces that alternated between laser-treated/machined and ma-chined/laser-treated. The experimental healing abutment was removed after 30 ± 7 days, which coincided with the soft tissue biopsy.


Eligibility criteria: Inclusion Criteria:

* Patients between 18 and 75 years
* Patients with no systemic and/or oral health disease
* At least six months of healing after tooth extraction
* Adequate dimension of the attached gingiva (\>2 mm) or keratinized tissue at the site selected and adequate residual bone crest

Exclusion Criteria:

* - Patients with poor oral hygiene
* Plaque score (PS) and bleeding on probing (BOP) more than 25%
* Patients with active periodontal disease
* Insufficient bone thickness for implant insertion and bone augmentation procedures
* patients who necessitate immediate implant loading protocols
* Uncontrolled diabetes mellitus
* Immune diseases
* Patients who smoke more than 10 cig/die

Primary outcomes:
measure: soft tissue adhesion
timeFrame: After a healing period of 12 ± 4 weeks, during the second surgical phase
Secondary outcomes:
measure: bacterial adhesion
timeFrame: After a healing period of 12 ± 4 weeks, during the second surgical phase
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: G. d'Annunzio University
state: CH
Study officials:
References: