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Comparison of the efficacy of bone graft on immediate implant

Clinical comparison of immediate implant placement with and without bone grafting (combination of Bioactive glass and Autograft) using resonance frequency analysis and implant health index: A Randomized Clinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180826040863N2
Enrollment
12
Registered
2026-02-05
Start date
2025-11-11
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Presence of tooth-root and mandibular implants. Presence of tooth-root and mandibular implants

Interventions

Intervention 1: Intervention group: At this stage, in the intervention group, the bone graft will consist of a 1:1 mixture of synthetic bone powder BaG type S53P4 (BonAlive®, Bonalive Biomaterials Ltd

Sponsors

Rasht University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: Patients aged 20 to 45 years Systemically healthy (blood pressure, diabetes mellitus) Healthy in terms of bone metabolism Presence of a non-retainable residual tooth or root of the maxillary first or second premolar

Exclusion criteria

Exclusion criteria: Patients with a history of any underlying disease Patients with a history of radiation therapy and chemotherapy Abnormalities related to the jaw and facial area Tobacco and cigarette use Pregnancy and lactation Active signs of infection such as pain, swelling, pus, abscess, and periapical lesion Advanced periodontitis and marginal bone loss, buccal plate perforation, type II or III socket Bruxism Poor cooperation in referring for follow-up sessions

Design outcomes

Primary

MeasureTime frame
Resonance Frequency Analysis, reported as the Implant Stability Quotient, will be measured to evaluate and compare the clinical outcomes of the intervention on implant stability between the first and second intervention groups. Timepoint: RFA will be measured and recorded immediately after completion of the surgery and suturing of the surgical site by the third investigator. The measurement of this index will be repeated 1 month and 3 months after surgery. Method of measurement: RFA is associated with the primary stability of the implant, such that a higher ISQ value indicates greater primary stability. To measure RFA, the Osstell Mentor device (Osstell AB, Gothenburg, Sweden) will be used. This device consists of a probe and a sensor; the sensor is attached to the implant, and the probe emits pulses. The sensor then vibrates in response, and the Osstell Mentor device records the RFA value.;Implant survival/success will be measured using the Implant Health Scale to evaluate and compare the clinical outcomes of the intervention between the first and second intervention groups. Timepoint: For this purpose, implant survival/success will be assessed 1 month and 3 months after surgery, and each implant will be assigned a score from 1 to 4. Method of measurement: A score of **1** indicates **Success (optimum health)**, defined by the absence of pain and tenderness during function, no mobility, bone loss less than 2 mm, and absence of exudate.A score of **2** indicates **Satisfactory survival**, defined by the absence of pain and tenderness during function, no mobility, bone loss of 2–4 mm, and absence of exudate.A score of **3** indicates **Compromised survival**, defined by possible pain and tenderness during function, no mobility, bone loss greater than 4 mm (or less than half of the implant length), probing depth greater than 7 mm, and possible presence of exudate.A score of **4** indicates **Failure (complete failure)**, defined by pain and tenderness during function,

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmirhossein Sohrabifar

Rasht University of Medical Sciences

Amirhosseinsohrabifar@gmail.com+98 13 3348 6421

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026