Effect of Bone Graft Material ON Peri-Implant Phenotype .

NCT07835451 | Completed

• 1 other identifier: MUOSU/POST-202609
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective three-arm controlled interventional clinical study evaluates the effects of NanoBone alone and NanoBone combined with platelet-rich fibrin (PRF) on peri-implant hard and soft tissue phenotype after dental implant placement. Thirty-nine adult participants requiring dental implant therapy will be assigned to three groups of 13 using a repeating sequential 1-2-3 allocation sequence: implant placement alone (control), implant placement with NanoBone, or implant placement with NanoBone and PRF/CGF membrane. Clinical and radiographic outcomes will be assessed at baseline, immediately after surgery, 8 weeks after surgery, and 4 months after surgery, with an early postoperative assessment of pain, swelling, medication use, and wound healing.

Conditions

Dental Implant

Keywords

Dental Implant; PRF; Bone Graft; Soft tissue

Outcome Measures

Primary Outcomes (5)

• Ridge Width Changes (RW)

  Bassline, Immediately after surgery, 8 weeks after surgery, and 16 weeks after surgery

• Bone Width (BW)

  Baseline (preoperative), and 16 weeks after surgery.

• Change in width of keratinized tissue (KTW)

  Baseline (preoperative), 8 weeks after surgery and 16 weeks after surgery.

• Keratinized Tissue Thickness (KTT)

  Baseline (preoperative) and 16 weeks after surgery.

• Crestal Bone Height (BH)

  Immediate postoperative and 16 weeks after surgery.

Secondary Outcomes (4)

• Plaque Index (PI)

  Baseline (preoperative), 8 weeks after surgery and 16 weeks after surgery.

• Bleeding On Probing (BOP)Index .

  Baseline (preoperative), 8 weeks after surgery and 16 weeks after surgery.

• Postoperative Pain ( Visual Analog Scale (VAS) )

  Postoperative First week daily 3 Times (morning, afternoon, evening)

• Postoperative Swelling Severity Using a Four-Point Likert Scale

  Postoperative First week daily 3 Times (morning, afternoon, evening)

Study Arms (3)

Control Group

ACTIVE COMPARATOR

Participants receive dental implant placement without the addition of bone graft material or bone substitute.

Procedure: Dental implant placement

Group 2: Dental Implants + Nanobone

EXPERIMENTAL

Patients receive dental implants combined with Nanobone

Other: NanoBone

Group 3: Dental implant with Nanobone and PRF

EXPERIMENTAL

Patients receive standard dental implants placement with Nanobone and PRF

Other: NanoBone sticky bone plus CGF/PRF membrane

Interventions

Dental implant placement PROCEDURE

Dental implant placement without adding bone graft material or bone substitute at the implant site, according to the study protocol.

Control Group

NanoBone OTHER

Application of NanoBone at the implant site during dental implant placement.

Group 2: Dental Implants + Nanobone

NanoBone sticky bone plus CGF/PRF membrane OTHER

Application of NanoBone sticky bone combined with a CGF/PRF membrane at the implant site during dental implant placement.

Group 3: Dental implant with Nanobone and PRF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older, of either sex.
• Patients able to maintain an acceptable standard of oral hygiene and comply with study instructions.
• Healed edentulous ridges scheduled for delayed implant placement at least six months after tooth extraction.
• Straightforward implant sites with sufficient alveolar bone height and width for conventional implant placement.
• Systemically healthy patients without a medical condition expected to interfere with surgery, wound healing, or osseointegration.
• The implant location was required to be devoid of previous bone augmentation operations.
• Absence of behavioral or psychological conditions that could compromise treatment cooperation or follow-up attendance.
• Loss of one or more teeth requiring implant-supported rehabilitation.

You may not qualify if:

• Uncontrolled systemic disease or any condition that could impair normal healing or prevent safe surgical treatment, including uncontrolled diabetes mellitus.
• Current pregnancy.
• Active periodontal, periapical, or other infection or inflammation at the planned implant site.
• Severe ridge deficiency requiring complex reconstruction rather than the standardized study procedure.
• Metabolic bone disorders, including severe osteoporosis or osteogenesis imperfecta.
• Parafunctional habits such as bruxism or clenching.
• Limited mouth opening that could restrict clinical measurements or surgical access.
• Anatomical limitations that prevented safe implant placement without additional modification, including close proximity to major nerves or the maxillary sinus.
• Inability or unwillingness to attend the scheduled follow-up visits.
• Individuals who adhere to social customs such as smoking, chewing tobacco, or consuming alcohol

Sponsors & Collaborators

• Al-Mustansiriyah University: lead

Study Sites (1)

Mustansiriyah University - College of Dentistry

Baghdad, Iraq

Location

MeSH Terms

Interventions

NanoBone

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Three parallel groups with consecutive enrollment and a pre-established repeating 1-2-3 sequential cyclic allocation. The predictable sequence was used to maintain balanced group sizes; allocation was not true randomization.

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 23, 2026
• Study Start: July 2, 2026
• Primary Completion: September 1, 2026
• Study Completion: September 1, 2026
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)