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

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: Recruiting
• Conditions: Alveolar Bone Loss; Tooth Extraction
• Intervention / Treatment: Procedure: Reduced time interval treatment protocol; Procedure: Standard time interval treatment protocol

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: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: GABRIELA GUADALUPE ZAMBRANO MANZABA, DDS; Phone Number: +19546298543; Email: gabriela.manzaba30@gmail.com

Study Locations

• Ecuador
  • Guayas
    • Guayaquil, Guayas, Ecuador, 090101
      • Recruiting
      • Universidad Catolica Santiago de Guayaquil- Carrera de Odontologia de La Ucsg
      • Contact: GABRIELA GUADALUPE ZAMBRANO MANZABA, DDS; Phone Number: +1 9546298543; Email: gabriela.manzaba30@gmail.com
      • Contact: GABRIELA ZAMBRANO MANZABA, DDS; Phone Number: 9546298543; Email: gabriela.manzaba30@gmail.com
      • 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Mean change in horizontal alveolar ridge width (mm) measured by cone-beam computed tomography (CBCT)	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

Outcome Measure	Measure Description	Time Frame
Mean change in vertical alveolar bone height (mm) measured by cone-beam computed tomography (CBCT)	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)	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	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)	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

• Sponsor: Universidad Catolica Santiago de Guayaquil
• Collaborators: Klockner Implant System

Publications and helpful links

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

• Institutional website of Universidad Católica de Santiago de Guayaquil where the study is conducted.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 27, 2027

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Guided Bone Regeneration; Dental implant; Alveolar ridge preservation; Bone regeneration; Tooth extraction; Dental Implant Placement
• Additional Relevant MeSH Terms: Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Alveolar Bone Loss
• Other Study ID 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