Reduced Time Interval for Implant Placement After Extraction Socket Preservation Using the Vega Plus Implants

Official title

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

Overview

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.

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.

Interventions

• 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.
• Procedure Standard time interval treatment protocol
  Participants receive implant placement after extraction socket preservation following the conventional healing interval used in routine clinical practice.

Primary outcome measures

• 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)]

Secondary outcome measures (4)

• 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)]
• Mean implant stability quotient (ISQ) measured using resonance frequency analysis (Osstell IDx) [Time frame: 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]
• Mean postoperative pain score measured using the Visual Analog Scale (VAS, 0-10) [Time frame: 24 hours to 14 days after implant placement surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Ecuador · 1 center

• Universidad Catolica Santiago de Guayaquil- Carrera de Odontologia de La Ucsg — Guayaquil

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, Tozum TF. Morphological Classification of Extraction Sockets and Clinical Decision Tree for Socket Preservation/Augmentation after Tooth Extraction: a Systematic Review. J Oral Maxillofac Res. 2019 Sep 5;10(3):e3. doi: 10.5037/jomr.2019.10303. eCollection 2019 Jul-Sep. PMID 31620265
• Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hammerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40(1):90-8. doi: 10.1111/jcpe.12027. Epub 2012 Nov 19. PMID 23163915
• Araujo MG, Silva CO, Misawa M, Sukekava F. Alveolar socket healing: what can we learn? Periodontol 2000. 2015 Jun;68(1):122-34. doi: 10.1111/prd.12082. PMID 25867983
• Hammerle CH, Araujo MG, Simion M; Osteology Consensus Group 2011. Evidence-based knowledge on the biology and treatment of extraction sockets. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:80-2. doi: 10.1111/j.1600-0501.2011.02370.x. PMID 22211307
• Tan WL, Wong TL, Wong MC, Lang NP. A systematic review of post-extractional alveolar hard and soft tissue dimensional changes in humans. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:1-21. doi: 10.1111/j.1600-0501.2011.02375.x. PMID 22211303

Identifiers

NCT: NCT07484685 · 1728937721

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗