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NCT Number: NCT07709676

Beta-Tricalcium Phosphate Grafting of Peri-implant Jumping Gaps Greater Than 2 mm in Immediate Implants

This randomized controlled trial evaluated whether grafting the peri-implant "jumping gap" with injectable β-tricalcium phosphate (β-TCP) improves outcomes after immediate implant placement in sites where the horizontal gap between the implant surface and the surrounding socket wall exceeds 2 mm. Sixteen patients (a total of 39 immediate implants in the maxillary anterior and premolar regions) were randomly allocated in a 1:1 ratio to a test group (peri-implant gap filled with injectable β-TCP) or a control group (no grafting). The patient was the unit of analysis. The primary outcome was implant stability, measured by resonance frequency analysis and expressed as the implant stability quotient (ISQ) at baseline, 3 months, and 6 months. The secondary outcome was peri-implant bone density, monitored on standardized digital periapical radiographs (baseline, 3, and 6 months) and quantified at 6 months by a single cone-beam computed tomography (CBCT) scan.

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Key information

Conditions

Tooth Loss in the Anterior Maxilla Alveolar Bone Loss Alveolar Bone Loss* / Therapy Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Suez Canal University

Ismailia, Egypt

About this study

Design: single-center, prospective, parallel-group, randomized controlled trial with a 1:1 allocation ratio. Ethical approval was obtained from the Research Ethics Committee, Faculty of Dentistry, Suez Canal University (approval no. 682/2023), and all procedures were performed in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants.

Participants: patients aged 20-50 years requiring extraction of a non-restorable maxillary anterior or premolar root, with a peri-implant jumping gap greater than 2 mm at the implant site.

Interventions: after atraumatic extraction and prosthetically driven osteotomy preparation, implants were placed at the crestal level. In the test group the peri-implant gap was filled with injectable β-TCP; in the control group no grafting was performed.

Randomization and blinding: the allocation sequence was computer-generated by an investigator not involved in surgery, with concealment by sequentially numbered, opaque, sealed envelopes. Outcome assessors, including the radiographic bone-density readers, were blinded to group allocation.

Outcomes: the primary outcome was implant stability (ISQ) at baseline, 3, and 6 months. Secondary outcomes were peri-implant bone density on periapical radiographs (Digora grayscale, 0-255) and on a single 6-month CBCT (gray-value-derived HU-equivalent radiodensity), and implant survival. Analysis used independent-samples t tests for between-group and repeated-measures ANOVA for within-group comparisons (α = 0.05), with the patient as the unit of analysis.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 20 to 50 years
  • Non-restorable maxillary anterior or premolar tooth requiring extraction and immediate implant placement
  • Peri-implant jumping gap greater than 2 mm at the implant site
  • Adequate inter-arch space
  • Good patient compliance

Exclusion criteria

  • • Systemic disease affecting healing
  • Smoking of more than 10 cigarettes per day
  • Parafunctional habits
  • Poor oral hygiene
  • Active periodontal disease

Treatment and study plan

Experimental: Test: beta-tricalcium phosphate grafting

Device

A β-tricalcium phosphate synthetic bone substitute supplied ready-to-use in a putty carrier (Bonegraft Biomaterials Co., Ltd., Daegu, South Korea), placed into the peri-implant jumping gap (greater th

Primary outcomes

  1. Implant stability (implant stability quotient, ISQ)

    Time frame: Baseline (immediately postoperative), 3 months, and 6 months

    Implant stability measured by resonance frequency analysis and expressed as the ISQ (unitless, 1-100; higher = more stable). The patient was the unit of analysis; for patients with more than one implant, the mean ISQ of that patient's implants was used.

Secondary outcomes

  1. Peri-implant bone density on periapical radiographs (Digora grayscale)

    Time frame: Baseline, 3 months, and 6 months

    Bone density on standardized digital periapical radiographs (paralleling technique, fixed exposure), analyzed with Digora software as grayscale values (0-255) at the mesial, distal, and apical regions.

  2. Peri-implant radiodensity on 6-month cone-beam CT (HU-equivalent)

    Time frame: 6 month

    Radiodensity on a single 6-month CBCT along the buccal aspect of each implant at apical, middle, and crestal levels, expressed as gray-value-derived HU-equivalent values; read independently by two blinded radiologists.

  3. Implant survival

    Time frame: 6 months

    Proportion of implants surviving to the 6-month follow-up, with assessment of infection, implant mobility, and wound dehiscence at each visit.

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Effect of Beta-Tricalcium Phosphate (β-TCP) Grafting on Implant Stability and Peri-implant Bone Density Following Immediate Implant Placement in Sites With Jumping Gaps Exceeding 2 mm: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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