Reduced Time Interval for Implant Placement After Extraction Socket Preservation Using the Vega Plus Implants (RIP-VEGA)

April 27, 2026 updated by: Gabriela Guadalupe Zambrano Manzaba, Universidad Catolica Santiago de Guayaquil

Effect of Reducing the Time Interval for Implant Placement After Extraction Socket Preservation Using the Vega Plus Implant System (Klockner): A Randomized Controlled Clinical Trial

This randomized controlled clinical trial aims to evaluate whether reducing the healing interval for implant placement after extraction socket preservation improves clinical and radiographic outcomes compared with the conventional waiting period. Participants requiring single-tooth extraction and implant therapy will be randomly assigned to implant placement either 4 months or 6 months after ridge preservation using the Vega Plus implant system (Klockner).

Clinical and radiographic assessments will be performed at baseline and during follow-up visits. The primary outcome will be the mean change in horizontal alveolar ridge width measured using cone-beam computed tomography (CBCT). Secondary outcomes will include vertical bone height changes measured on CBCT, implant stability measured using resonance frequency analysis (ISQ values), marginal bone level changes assessed on standardized periapical radiographs, and postoperative pain assessed using the Visual Analog Scale (VAS).

The results of this study may contribute to optimizing treatment timing and improving efficiency in implant dentistry while maintaining favorable clinical outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The optimal interval between treatment phases remains uncertain in several clinical settings. Traditional protocols often include a waiting period between phases to allow tissue healing or stabilization; however, prolonged intervals may extend overall treatment time and potentially affect patient adherence and outcomes. Emerging evidence suggests that reducing the interval between phases could maintain clinical effectiveness while improving efficiency and patient satisfaction. This randomized controlled trial will compare a reduced-interval protocol with a conventional-interval protocol. Eligible participants who require multi-phase treatment will be randomized into two groups: (1) reduced-interval treatment and (2) standard-interval treatment. Clinical examinations will be conducted at baseline and at scheduled follow-up visits according to the study protocol.

Primary outcomes will assess clinically relevant parameters associated with the treated condition. Secondary outcomes will evaluate treatment duration, patient-reported symptoms, and quality-of-life measures. Statistical analyses will compare outcomes between groups to determine whether the reduced-interval approach provides equivalent or improved results compared with the conventional schedule.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Ecuador
    • Guayas
      • Guayaquil, Guayas, Ecuador, 090101
        • Recruiting
        • Universidad Catolica Santiago de Guayaquil- Carrera de Odontologia de La Ucsg
        • Contact:
        • Contact:
        • Principal Investigator:
          • GABRIELA G ZAMBRANO MANZABA, DDS
        • Sub-Investigator:
          • MANUEL TOLEDANO PEREZ, DDS
        • Sub-Investigator:
          • RAQUEL OSORIO RUIZ, DDS
        • Sub-Investigator:
          • MANUEL TOLEDANO OSORIO, DDS
        • Sub-Investigator:
          • MARIA C VALLECILLO, DDS
        • Sub-Investigator:
          • JAVIER GIL, DDS
        • Sub-Investigator:
          • HECTOR A LEMA GUTIERREZ, DDS
        • Sub-Investigator:
          • ALEJANDRA TORRES SOSA, DDM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age: ≥ 18 years.
  • Good general health.
  • Need of extraction of incisors, canines or premolars due to carious lesion, endodontic complication, root fracture or prosthetic reason.
  • Presence of three intact socket walls after tooth extraction with a defect of 50% or more of the buccal wall.
  • Need of single-tooth implant treatment, with presence of adjacent teeth and opposing occluding teeth (for measurement stent indexing).
  • Enough available bone assessed on CBCT to place implants with 3.6 mm diameter and 10 mm in length.
  • Periodontal health in intact or reduced periodontium.
  • Full-mouth plaque and bleeding scores < 20%.
  • Able and willing to follow study procedures and instructions.

Exclusion Criteria:

  • < 18 years.
  • Compromised health. Existence of any systemic condition such as uncontrolled diabetes mellitus, cancer, HIV, disorders that compromise wound healing, chronic high dose steroid therapy, intravenous and oral bisphosphonate therapy, bone metabolic diseases, history of irradiation of the head and neck area, or any other immunosuppressive therapy that would contraindicate oral surgical treatment.
  • Absence of any adjacent teeth or the opposing occluding teeth.
  • The hopeless tooth is a molar.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Reduced time Interval treatment protocol
Participants receive implant placement after extraction socket preservation using a reduced healing interval according to the experimental protocol.
Procedure: Reduced time interval treatment protocol
Participants receive treatment phases with a reduced time interval between sessions according to the experimental protocol in order to evaluate whether shortening the interval improves clinical outcomes and treatment efficiency.
Active Comparator: Standard Time Interval
Participants receive treatment following the conventional interval protocol used in routine clinical practice.
Procedure: Standard time interval treatment protocol
Participants receive implant placement after extraction socket preservation following the conventional healing interval used in routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean change in horizontal alveolar ridge width (mm) measured by cone-beam computed tomography (CBCT)
Time Frame: Baseline (immediately after ridge preservation surgery) to 6 months after surgery (prior to implant placement)
Horizontal alveolar ridge width will be measured in millimeters using cone-beam computed tomography (CBCT). Measurements will be obtained at three standardized levels (1 mm, 3 mm, and 5 mm below the crestal bone). Baseline and follow-up CBCT scans will be superimposed, and the mean change in ridge width (mm) between time points will be calculated.
Baseline (immediately after ridge preservation surgery) to 6 months after surgery (prior to implant placement)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean change in vertical alveolar bone height (mm) measured by cone-beam computed tomography (CBCT)
Time Frame: Baseline (immediately after ridge preservation surgery) to 6 months after surgery (prior to implant placement)
Vertical alveolar bone height will be measured in millimeters using CBCT by determining the distance between the crestal bone (line C) and the apical reference line (line A). Baseline and follow-up CBCT scans will be superimposed, and the mean change in vertical bone height will be calculated.
Baseline (immediately after ridge preservation surgery) to 6 months after surgery (prior to implant placement)
Mean implant stability quotient (ISQ) measured using resonance frequency analysis (Osstell IDx)
Time Frame: Implant placement to prosthetic loading (approximately 3 months)
Implant stability will be measured using resonance frequency analysis with the Osstell IDx device. Implant Stability Quotient (ISQ) values will be recorded in mesiodistal and buccolingual directions, and the mean ISQ value will be calculated for each implant.
Implant placement to prosthetic loading (approximately 3 months)
Mean marginal bone level change (mm) measured on standardized periapical radiographs
Time Frame: Implant placement to 2 years after prosthetic loading
Marginal bone levels will be measured using standardized digital periapical radiographs obtained with a parallel technique and individualized film holders. The distance from the implant-abutment junction to the first bone-to-implant contact will be measured mesially and distally, and the mean marginal bone level change will be calculated.
Implant placement to 2 years after prosthetic loading
Mean postoperative pain score measured using the Visual Analog Scale (VAS, 0-10)
Time Frame: 24 hours to 14 days after implant placement surgery
Postoperative pain will be assessed using the Visual Analog Scale ranging from 0 (no pain) to 10 (worst imaginable pain). The mean pain score will be calculated.
24 hours to 14 days after implant placement surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Catolica Santiago de Guayaquil

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Klockner Implant System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Brånemark PI, Zarb GA, Albrektsson T. Tissue-integrated prostheses: osseointegration in clinical dentistry. Quintessence Publishing; 1985.
  • Juodzbalys G, Stumbras A, Goyushov S, Duruel O, Tözüm TF. Morphological classification of extraction sockets and clinical decision tree for socket preservation. J Oral Maxillofac Res. 2019;10:e3.
  • Jung RE, Philipp A, Annen BM, et al. Radiographic evaluation of different techniques for ridge preservation after tooth extraction. J Clin Periodontol. 2013;40:90-98.
  • Araújo MG, Silva CO, Misawa M, Sukekava F. Alveolar socket healing: what can we learn? Periodontol 2000. 2015;68:122-134.
  • Hämmerle CHF, Araújo MG, Simion M. Evidence-based knowledge on the biology and treatment of extraction sockets. Clin Oral Implants Res. 2012;23(Suppl 5):80-82.
  • Tan WL, Wong TLT, Wong MCM, Lang NP. A systematic review of post-extractional alveolar hard and soft tissue dimensional changes in humans. Clin Oral Implants Res. 2012;23(Suppl 5):1-21.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 27, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1728937721

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) that underlie the results reported in publications will be shared with qualified researchers upon reasonable request after publication of the study results.

IPD Sharing Time Frame

Data will be available beginning 6 months after publication of the study results and will remain available for up to 5 years.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal may request access to the de-identified data. Requests should be directed to the principal investigator. Data will be shared for purposes of scientific research and meta-analysis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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