NCT07484685

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Feb 2026Feb 2027

Study Start

First participant enrolled

February 28, 2026

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 20, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

March 12, 2026

Last Update Submit

April 27, 2026

Conditions

Alveolar Bone LossTooth Extraction

Keywords

Dental implantTooth extractionAlveolar ridge preservationGuided Bone RegenerationBone regenerationDental Implant Placement

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Mean change in vertical alveolar bone height (mm) measured by cone-beam computed tomography (CBCT)

    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 placement to prosthetic loading (approximately 3 months)

  • Mean marginal bone level change (mm) measured on standardized periapical radiographs

    Implant placement to 2 years after prosthetic loading

  • Mean postoperative pain score measured using the Visual Analog Scale (VAS, 0-10)

    24 hours to 14 days after implant placement surgery

Study Arms (2)

Reduced time Interval treatment protocol

EXPERIMENTAL

Participants receive implant placement after extraction socket preservation using a reduced healing interval according to the experimental protocol.

Procedure: Reduced time interval treatment protocol

Standard Time Interval

ACTIVE COMPARATOR

Participants receive treatment following the conventional interval protocol used in routine clinical practice.

Procedure: Standard time interval treatment protocol

Interventions

Reduced time interval treatment protocolPROCEDURE

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.

Reduced time Interval treatment protocol
Standard time interval treatment protocolPROCEDURE

Participants receive implant placement after extraction socket preservation following the conventional healing interval used in routine clinical practice.

Standard Time Interval

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \< 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guayaquil, Guayas, 090101, Ecuador

RECRUITING

Related Publications (6)

  • Brånemark PI, Zarb GA, Albrektsson T. Tissue-integrated prostheses: osseointegration in clinical dentistry. Quintessence Publishing; 1985.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • Araújo MG, Silva CO, Misawa M, Sukekava F. Alveolar socket healing: what can we learn? Periodontol 2000. 2015;68:122-134.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

GABRIELA GUADALUPE ZAMBRANO MANZABA, DDS

CONTACT

+19546298543gabriela.manzaba30@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to two parallel groups: one group receiving treatment with a reduced time interval between phases and a control group receiving treatment according to the conventional interval protocol. Outcomes will be compared between groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in Periodontology

Study Record Dates

First Submitted

March 12, 2026

First Posted

March 20, 2026

Study Start

February 28, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

February 27, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be available beginning 6 months after publication of the study results and will remain available for up to 5 years.
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.

Locations

EC(1)