Clinical trial NCT06177275: The Influence of Vertical Implant Position on the Marginal Bone Loss in Thick Versus Thin Phenotype.
Official title: The Influence of Vertical Implant Position With Immediate Provisionalization on the Marginal Bone Loss in Thick Versus Thin Phenotype. A Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Implant
Vertical Position
Esthetic Zone
Bounded Edentulous Area
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multiple clinical studies have established high survival rates and tremendous predictability of dental implant treatment (Schiegnitz and Al-Nawas 2018). However, a pleasant esthetic outcome is the patient's primary expectation regarding implants in the esthetic zone (Vermylen et al. 2003)and several esthetic factors have been evaluated to contribute to an esthetic appearance. Among these, the midfacial soft tissue level is considered to be one of the most important factors; Cosyn and co-workers reported that among factors including soft tissue phenotype, the midfacial recession was associated with the position of the implant (Cosyn et al. 2012).

Therefore, subcrestal implant placement has been advocated as it has been associated with the reduction of crestal bone loss in cases with decreased soft tissue thickness. If the vertical soft tissues on the crest of the alveolar ridge are 2 mm or less at the time of implant placement, implants will undergo unavoidable bone resorption by establishing sufficient biologic protection. Another option was proposed by Linkevicius et al, who introduced the subcrestal implant placement as a method to accommodate the problem of thin soft tissues.(Linkevicius et al. 2020).

Limiting the extent of peri-implant bone loss has been recognized for decades to be an important aspect of long-term implant success, and stable peri-implant bone conditions play an important role in maintaining esthetics (Laurell and Lundgren, 2011).

The opinion expressed widely in the scientific literature has been that subcrestal implant placement leads to increased crestal bone resorption. However, clinical studies addressing the implant placement depth in relation to crestal bone have been rare. Data on subcrestal versus crestal placement have mostly come from animal studies. Even fewer data are available regarding the effects of crestal versus subcrestal positioning of platform-switched implants (Cochran et al., 2009).

This study aims to compare the effect of different vertical implant position with immediate provisionalization on marginal bone loss thin and thick vertical tissue biotype.


Eligibility criteria: Eligibility criteria:

Inclusion criteria:

* Patients with single missing upper anterior or premolar teeth
* Patients with minimum buccolingual width of 6 mm and mesiodistal width of 6mm
* Patients with healthy systemic conditions.
* Patients older than 18 years.
* Good oral hygiene.
* Accepts one year follow-up period (cooperative patients).
* The patient provides informed consent.
* Adequate Inter-arch space for implant placement.
* Favorable occlusion (no traumatic occlusion).
* Absence of allergy to the prescribed medications.

Exclusion criteria:

* Patients with inadequate bone volume and/ or quality
* Patients with local root remnants
* Patients with inadequate wound healing
* Patients with signs of acute infection related to the area of interest.
* Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits (Lobbezoo et al., 2006).
* Heavy smokers patients (more than 10 cigarettes per day) (Lambert, Morris and Ochi, 2000).
* Metabolic diseases such as diabetes or hyperthyroidism as well as systemic medications such as chemotherapy or bisphosphonates
* Pregnant or nursing women.
* Uncooperative patients.

Primary outcomes:
measure: Crestal bone loss
timeFrame: 1 year
Secondary outcomes:
measure: Radiographic horizontal bucco-palatal bone changes
timeFrame: 1 year
measure: Radiographic vertical bone changes
timeFrame: 1 year
measure: Midfacial recession (MFR):
timeFrame: easured at 6, and 12 months
measure: Esthetic evaluation
timeFrame: 1 year
measure: implant survival
timeFrame: 1 year
measure: Emergence Angle
timeFrame: 1 year
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
References: