The Influence of Vertical Implant Position With Immediate Provisionalization on the Marginal Bone Loss.

NCT05973357 | Unknown

• 1 other identifier: 1407
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Multiple clinical studies have established high survival rates and tremendous predictability of dental implant treatment. However, a pleasant esthetic outcome is the patient's primary expectation regarding implants in the esthetic zone 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 . 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. Research question: Does the placement of delayed implants with different vertical depth affect the marginal bone loss with immediate provisionalization?

Conditions

Dental Implant Failed; Implant Site Reaction

Keywords

Delayed Implant; Immediate loading; Temporization; provisionalization

Outcome Measures

Primary Outcomes (1)

• Marginal bone loss

  Crestal bone loss

  1 year follow up

Secondary Outcomes (5)

• Mid facial recession

  1 year follow up

• The pink esthetic score

  1 year follow up

• Gingival Thickness

  1 year follow up

• Implant Survival

  1 year follow up

• Post-operative patient satisfaction

  1 year follow up

Study Arms (2)

Sub-crestal group

EXPERIMENTAL

Patients receiving delayed implant placed 2mm sub-crestal level with immediate provisionalization

Procedure: Sub-crestal implant

Equi-crestal grouo

EXPERIMENTAL

Patients receiving delayed implant placed equi-crestal level with immediate provisionalization

Procedure: Equi-crestal implant

Interventions

Sub-crestal implant PROCEDURE

Patients receiving delayed implant placed 2mm sub-crestal level with immediate provisionalization

Sub-crestal group

Equi-crestal implant PROCEDURE

Patients receiving delayed implant placed equi-crestal level with immediate provisionalization

Equi-crestal grouo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ● 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.

You may not qualify if:

• ● 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.

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 2, 2023
• Study Start: September 20, 2023
• Primary Completion: September 20, 2025
• Study Completion: October 30, 2025
• Last Updated: August 2, 2023

Record last verified: 2023-08