May geometric modifications of implants influence implant repair in smokers?
- Conditions
- SmokingTooth Lossk081
- Registration Number
- RBR-10gjvcyt
- Lead Sponsor
- niversidade Paulista
- Brief Summary
This split-mouth, doble-blind, randomized clinical trial aimed at evaluating the impact of different macrogeometries and nanotopographical modifications on peri-implant bone repair in smokers. Thirty-two patients who smoked at least 10 cigarettes/day, with the need of a single maxillary or mandibular implant bilaterally, received two implants randomly assigned to: DA - Dual Acid-Etched implants (n=32); HCAN – healing chambers and activated nanosurface (n=32). Implant stability quotient (ISQ) was evaluated at 07, 30, 60, 90 and 120 days after implant placement. Levels of bone and angiogenic markers were quantified in the peri-implant fluid after 07, 15, 30, 90 and 120 days of implant insertion. HCAN implants higher ISQ than DA implants at 60 days (p<0.05). PLGF levels were lower for HCAN implants than to DA implants at 07 days period (p<0.05). Besides, HCAN implants presented higher levels of OPG at 30 days period and OPN, BMP-9, FGF-1, PLGF and VEGF at 90 days period, when compared to DA implants (p<0.04). The levels of EGF were higher for HCAN implants at 15, 90 and 120 days comparing with DA implants (p<0.05). HCAN implants also showed lower levels of TNF-a at 07 days (p<0.05) in comparison to DA implants (p<0.05) but had higher levels of DKK1 at 30 days in while DA implants presented higher level of this marker at 90 days (p<0.05). Macrogeometry and nanotopographical modifications positively modulated the bone and angiogenic factors resulting in higher production of these markers during early peri-implant bone healing and had positive effect on implant stabilization in smokers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Data analysis completed
- Sex
- Not specified
- Target Recruitment
- Not specified
Smokers who smoke more than 10 cigarettes/day; aged between 18 and 65 years; both genders; with the presence of at least 20 teeth in the oral cavity; bilateral and homologous unitary prosthetic space
Presence of systemic diseases that could interfere with bone regeneration, such as diabetes, arthritis, hypothyroidism, hyperparathyroidism, and osteoporosis; pregnancy or breastfeeding; use of medications that counter-indicated the performance of surgical procedures or that could alter bone regeneration around implants (e.g., anti-inflammatory and bisphosphonate drugs); absence of keratinized tissue at the implant insertion sites (may interfere with hygiene around the implants); need for bone or tissue grafts
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Expected outcome 1: Modifications in the implant geometry are expected to positively influence the bone markers studied, through immunoenzymatic analysis, increasing the concentration (pg/ml) of osteoblastogenic and angiogenic markers and reducing the concentration (pg/ml) of osteoclastogenic markers.;Found outcome 1: Using immunoenzymatic analysis, higher levels (pg/ml) of osteoblastogenic and angiogenic markers were observed in the presence of geometric modifications of the implants.
- Secondary Outcome Measures
Name Time Method Expected outcome 2: It is expected that periodic modifications will contribute to increasing the stability quotient of affected implants through resonance frequency analysis;Found outcome 2: It was found in the resonance frequency analysis, that the implant stability quotient presented higher values for HCAN implants at 60-day time-point (early phase) <br>