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Immediate Implants in the Aesthetic Zone

Primary Stability and PES/WES Evaluation for Immediate Implants in the Aesthetic Zone: a Clinical Double-blind Randomized Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04343833
Enrollment
20
Registered
2020-04-13
Start date
2017-10-02
Completion date
2020-04-04
Last updated
2020-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immediate Dental Implant

Keywords

Dental esthetics, Primary stability, Single-tooth restoration, Osseointegration.

Brief summary

The use of immediate implants in the aesthetic area is a technique widely used in modern implantology. The characteristics of the patient, the implant, and the surgical procedure used may influence the final results. The aim was to assess whether the implant design affects primary (PS) and secondary stability (SS), bone level (BL), and PES/WES evaluation.

Detailed description

20 implants with two different designs (n=10) were immediately placed in the upper anterior maxilla with no grafting material. ISQ, BL, and PES/WES were evaluated. Results will analyze with the Wilcoxon-Mann-Whitney test (p\<0.05). The random distribution is made prior to assignment following the internet prgram https://www.random.org

Interventions

At the time of operation, the tooth was atraumatically extracted, and the implant was immediately placed following the surgical protocol recommended by the manufacturer. A temporary prosthesis was made without occlusal contact.

Sponsors

Universidad de Murcia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

Double (participant, investigator)

Intervention model description

A total of 20 patients, distributed in two groups with ten patient each (experimental and control) were included in this study. All patients signed a double informed consent, one for implant placement and one for their participation in the study. The study follows the Declaration of Helsinki recommendations. The Ethics Committee of the University of Murcia approved the study protocol with ID: 2076/2018.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patients who presented aa vertical fracture in an upper incisor that can not be treated conservatively and ended in the extraction, and the treatment needed is a unitary implant. * Good systemic health status (ASA I or II). * Oral hygiene index of \< 2 (Löe and Silness). * A minimum of 2 mm of attached mucosa. * A minimum of 8 mm of vertical bone. * A minimum of 7 mm of bucco-lingual bone.

Exclusion criteria

* Traumatic or complicated incisor extraction. * Pregnant or women in the lactation period. * Use of any medication that contraindicates implant treatment. * A history of alcohol or drug abuse. * A requirement for guided bone regeneration. * A requirement for tissue graft augmentation. * Failure to comply with the study protocol.

Design outcomes

Primary

MeasureTime frameDescription
Bone levelAfter 12 months of definitive implant loadThe bone level (BL) was determined by an intraoral digital radiograph taken parallel to the long axis of the implant. The distance from the implant neck to the first contact between the bone and the implant was determined. It was measured in both sides, mesial and distal, and the mean between both values was established as the BL value.
PES/WESAfter 12 months of definitive implant loadPink Esthetic Score/White Esthetic Score \[PES/WES\] The parameters evaluated by this index are (1) mesial papilla, (2) distal papilla, (3) curvature of facial mucosa, (4) level of facial mucosa, and (5) root convexity/soft tissue color and texture. Each parameter range between 0 and 2. A maximum score of 10 can be obtained, considering acceptable from 6 The WES focuses specifically on the visible part of the restoration and in base on the following five parameters: (1) tooth form, (2) tooth volume/outline, (3) color (hue and value), (4) Surface texture, and (5) translucency. Each parameter is evaluated by comparison with the adjacent teeth, giving a value ranged from 0 to 2. A total score of 10 can be obtained, considering acceptable from 6

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026