NCT07675772

Brief Summary

\> Evaluation of the wound healing in immediate occlusal loading of endosseous delayed short dental implant with or without CGF or A-PRF. \> Detection of the primary and secondary implant stability of immediate occlusal loading of endosseous delayed short dental implant with or without CGF or A-PRF. \> Evaluation of the hard and soft tissue thickness after immediate occlusal loading of endosseous delayed short dental implant with or without CGF or A-PRF.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
48mo left

Started Jul 2026

Longer than P75 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Jul 2026Jul 2030

First Submitted

Initial submission to the registry

June 15, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 30, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

3 years

First QC Date

June 15, 2026

Last Update Submit

June 23, 2026

Conditions

Outcome Measures

Primary Outcomes (8)

  • Bleeding On Probing Index (BOP):

    BOP was regarded as an indicator of inflammation of the periodontal and peri-implant tissues. Gentle probing of the orifice of the gingival crevice. If bleeding occurs within 10 seconds a positive finding is recorded.

    at baseline, after 6 months, and after 12 months.

  • Peri- implant mucosal tissue index (MTI):

    This index was proposed as part of the Toronto study in light of the significance of mucosal inflammation on peri-implant conditions during monitoring. It is based on the appearance, consistency, and texture of the peri- implant mucosa. The scores are listed below: Score 0: Normal mucosa. Score 1: Mild inflammation with slight color change and edema. Score 2: Moderate inflammation with redness, edema, and glazing. Score 3: Severe inflammation, redness, edema, and ulceration.

    at baseline, after 6 months, and after 12 months.

  • Jemt papilla index:

    Index 0: No interproximal papilla is present. Index 1: Less than half of the height of the papilla is present (less than half of the distance between the imaginary cervical line and the interdental contact point). Index 2: At least half of the height of the papilla is present (half or more than half of the distance between the imaginary cervical line and the interdental contact point, however without filling up all interdental space). Index 3: The papilla is present and fills up the entire interdental space. Index 4: The gingival papilla is hyperplastic and covers part of the crown of the adjacent tooth or denture.

    at baseline, after 6 months, and after 12 months.

  • Probing Pocket Depth (PPD)

    The distance recorded in mm from the mucosal margin to the base of the pocket. According to the peri- implant condition, the PPD is often deeper (≥6 mm) in disease or shallower (\< 6 mm) in health. It should be emphasized, however, that deep PPD may be identified in the absence of disease in scenarios exhibiting thick crestal mucosa.

    at baseline, after 6 months, and after 12 months.

  • Modified plaque index (mPI):

    Score 0: No plaque. Score 1: Plaque disclosed by running a probe around the smooth marginal surface. Score 2: Plaque can be seen by the naked eye. Score 3: Abundance of soft matter.

    at baseline, after 6 months, and after 12 months.

  • Mucosal recession (MR)

    The distance in mm from the implant- abutment connection as a steady mark and the mucosal margin. If the mucosal margin exceeds coronally the implant- abutment connection due to swelling, the MR is positive , while if it is due to implant malposition or loss of support, the margin is apical to the implant- abutment connection and the value is negative.

    at baseline, after 6 months, and after 12 months.

  • Keratinized mucosa (KM)

    The distance measured from the free mucosal margin to the mucogingival junction at the buccal position line angles and recorded to the nearest mm. Arbitrarily, a 2 mm height was set as a threshold to define sufficient/presence or insufficient/lack.

    at baseline, after 6 months, and after 12 months.

  • Gingival thickness Measurement

    Before transgingival measurements, a xylocaine spray (10% lidocaine) is applied topically to reduce pain. It is measured by transgingival method from the buccal region using a #20 endodontic file (20 K-files). The measurement is made by transgingival method after determining the point corresponding to the base of the gingival sulcus with a periodontal probe. Then, the transgingival method measurement is made 1 mm apical to this point. An endodontic file with an attached plastic stopper was inserted perpendicularly into the gingiva until it reached the tooth or the bone. The distance between the stopper and the tip of the caliper is measured using a periodontal probe or digital caliper.

    at baseline, after 6 months, and after 12 months.

Secondary Outcomes (3)

  • Implant stability

    at baseline, after 6 months, and after 12 months.

  • Marginal bone loss

    at baseline, after 6 months, and after 12 months

  • Bone density Recording

    at baseline, after 6 months, and after 12 months

Study Arms (3)

1. Concentrated Growth Factors.

EXPERIMENTAL
Procedure: Dental Implant Surgery

2. Advanced Platelet Rich Fibrin.

EXPERIMENTAL
Procedure: Dental Implant Surgery

3. Natural healing.

EXPERIMENTAL
Procedure: Dental Implant Surgery

Interventions

Delayed Short Dental Implants with Immediate loading with or without growth factors.

1. Concentrated Growth Factors.2. Advanced Platelet Rich Fibrin.3. Natural healing.

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient aged 18 - 45 years old.
  • Patients maintaining excellent oral hygiene standards.
  • Systemically healthy patient.
  • Single or multiple missing teeth in premolar and molar region.
  • Patients should have adequate bone width volume (\>4 mm) and bone density with sufficient mesiodistal and interocclusal space. Bone height (≤10mm).
  • The patient should physically and psychologically be able to tolerate short implant surgical procedure.
  • Patient with a sufficient platelet count (\>200,000/mm3) for CGF and A-PRF preparation.
  • Patients who provided informed consent.

You may not qualify if:

  • \> Presence of active periodontal disease.
  • Patients with a significant medical history which contradicts placement of dental implants such as:
  • Diabetes.
  • Diseases affecting bone metabolism.
  • Patients currently on antibiotics, steroids, hormonal therapy, or medications known to affect bone metabolism.
  • Patients with a history of radiotherapy or chemotherapy, coagulation defects, or currently on anticoagulant treatment.
  • Pregnant or lactating women.
  • Patients with poor oral hygiene.
  • Habits such as khat chewing, smoking and alcohol intake.
  • Insufficient vertical interarch space.
  • Temporomandibular joint disorder.
  • Parafunctional habits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Dr.Ebrahim Esmail Al_Mutawakel, BDS, MSD, PhD candidate

CONTACT

Manal Mohammed Al-Hajri, Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Department of Periodontology-College of Dentistry-Sana'a University

Study Record Dates

First Submitted

June 15, 2026

First Posted

June 30, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2030

Last Updated

June 30, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

I am committed to maintain the complete confidentiality of the data, information, and identity of all participants.