Delayed Short Dental Implants With Immediate Loading

Clinical and Radiographic Evaluation of the Role of Concentrated Growth Factor (CGF) and Advanced Platelet-Rich Fibrin (A-PRF) in Enhancing the Wound Healing and Stability of Delayed Short Dental Implants With Immediate Loading: Randomized Controlled Clinical Trial

> 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.

Study Overview

• Status: Not yet recruiting
• Conditions: DENT IMPLANTS
• Intervention / Treatment: Procedure: Dental Implant Surgery

Detailed Description

The term 'short implant' is subjective. In most publications this is defined as an implant length between 5 mm and 10 mm. The first implants of this type and length of 7 mm were introduced in 1979 by the Bränemark system. Today, most implantology companies offer implants shorter than 8 mm, which has led to their common use in clinically substantiated cases. The use of shorter implants is indicated in the lateral parts of the maxilla and the mandible. These regions are the most predisposed to atrophy because first molars are the first teeth lost in most cases. After their extraction, the atrophy of bone surface develops in 30-90% of cases. The extraction of first molars can also be the cause of further negative processes such as the mesial inclination of second molars towards the hole, which generates improper occlusal loading, leading to local bone atrophy.

The placement of short implants in treating edentulous patients eliminates the need for complicated surgeries to place conventional implants. Patient satisfaction will be increased as it avoids augmentation procedures, which result in short, inexpensive treatment options. Applying short implants in extremely resorbed mandibles (less than 10 mm bone height) might reduce the risk of mandibular fracture during penetration in the symphysis region, preserving the integrity of the lower mandibular cortex. Several studies concluded that many factors directly influence the success rates of short implants: implant diameter, length, number, stress distribution around the implant, marginal bone loss, implant thread design, and loading strategy for the prosthesis.

It was suggested that a short implant provides low-cost, acceptable, time-saving treatment instead of a long implant placed in the augmented bone while rehabilitating a completely edentulous atrophic maxilla. Significant failures occur with long implants in different augmented sites. Also, conventional dental implants had a triple increase in the chance of complications during insertion compared to short implants. A 5mm × 5mm implant gives the same results as a standard long implant placed in augmented bone after three years of loading. The short implant may be the first choice compared to bone augmentation.

Immediate occlusal loading refers to full functional occlusal loading of an implant within 2 weeks of placement. The authors gave guidelines for successful immediate implant loading with implants have good primary stabilization (placement torque of more than 40 Ncm) can be immediately loaded.

Immediate loading protocols are best in situations where the patient cannot tolerate two-stage surgeries or multiple visits; also, improve esthetics, enhance function, and comfort are expected. Concerning marginal bone loss and implant survival rate, the loading protocol is thought to be not relevant in the clinical success. A review suggested no significant difference between conventional and immediate loading protocols for conventional (normal-sized) implants, and this study also confirmed it about short implants. However, another review suggested that clinicians should be cautious about using immediate loading protocols for dental implants in the single-tooth restorations in the anterior maxilla because of probable marginal bone remodeling and gingival changes.

The survival rate of the immediate-loaded short implants was not statistically different from the conventional. Overall, the survival rate of immediate-loaded short implants in the mandible is higher than the maxilla. Other study found, the mean peri-implant marginal bone loss around the immediately loaded short implants was less than 1 mm. Immediately-loaded short implants have lost 0.4/0.5 mm less marginal bone than the long implants (up to 1 year follow-up), In another study, the 3-years marginal bone remodeling for short implants was 1.25 ± 0.99 mm.

Concentrated Growth Factor (CGF) was developed by Sacco in the year 2006. It is produced by centrifuging venous blood, as a result of which the platelets are concentrated in a gel layer, comprising of a fibrin matrix rich in growth factors and leukocytes. CGF acts by degranulation of the alpha granules in platelets which play a vital role in early wound healing. It has been found that CGF contains more GFs than the other platelet-based preparations such as platelet rich fibrin (PRF) and platelet-rich plasma (PRP), and unlike PRP, CGF does not dissolve rapidly following application.

In vitro studies have established the beneficial effects of CGF in promoting bone regeneration around implants. Animal studies have also reported its potential merits. CGF is now emerging as a viable treatment option due to various reasons. First, it has the capability for extended release of GFs, presenting a stronger effect on enhancement of wound healing around implants. Second, it can be used alone or in combination with synthetic graft materials and facilitate osseointegration. Third, it is easy to prepare and manipulate, and it is inexpensive.

Advanced platelet rich fibrin (APRF) first described in 2014 as a new concept for cell-based tissue engineering with decreasing the rotations per minute (rpm) while increasing the time of standard platelet rich fibrin (PRF). More platelets were found in distal part of APRF compare to standard PRF. It is simple, safe and inexpensive process which required patient's own blood. It accelerates the wound healing and minimizes the discomfort. The autogenous nature of A-PRF makes it simple to use and manipulate. According to the studies in the literature stated above, A-PRF is utilized successfully and without any complications in the periodontal regeneration and healing process.

There is also no anticoagulant, which gives A-PRF better biological properties compared to classical PRF. The lower centrifugation parameters of A-PRF compared to PRF or Leukocyte-PRF (L-PRF) do not allow the platelets to be pushed down the tube. The advantage of lower centrifuge speed in A-PRF preparation is the improvement of properties. Neutrophils can migrate to the fibrin matrix. A-PRF is primarily used in surgical procedures. However, it can also be used in implantology (bone regeneration, socket preservation, alveolar ridge preservation, maxillary sinus augmentation), periodontics (in treatment recessions) and to enhance general wound healing (reduced pain, swelling or trismus).

Cone-beam computed tomography (CBCT) is the most widely recommended imaging modality for implant planning since it allows precise 3-dimensional measurements of the implant bone site and accurate identification of anatomical structures and their variations. In dentistry, CBCT has been positioned as the modality of choice for cross-sectional imaging as an application that certainly has tangible implications for implant therapy. Generally speaking, CBCT technology is perceived as a radiographic tool with increased accuracy, higher resolution, lower radiation dose, and reduced cost for patients compared with other volumetric imaging modalities for the assessment of mineralized tissues. This notion has driven a robust interest to adopt this technology for routine dental implantology.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr.Ebrahim Esmail Al_Mutawakel, BDS, MSD, PhD candidate; Phone Number: 00967772048083; Email: e.almutawakel@su.edu.ye
• Study Contact Backup: Name: Manal Mohammed Al-Hajri, Prof.; Phone Number: 00967779212007

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

-

• 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.

Exclusion Criteria:

• > 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1. Concentrated Growth Factors.	Procedure: Dental Implant Surgery; Delayed Short Dental Implants with Immediate loading with or without growth factors.
Experimental: 2. Advanced Platelet Rich Fibrin.	Procedure: Dental Implant Surgery; Delayed Short Dental Implants with Immediate loading with or without growth factors.
Experimental: 3. Natural healing.	Procedure: Dental Implant Surgery; Delayed Short Dental Implants with Immediate loading with or without growth factors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant stability	• Primary implant stability is the biomechanical stability of implants upon placement. With the Smart Peg in place, a Mega ISQ Osstell probe, positioned perpendicular to the Smart Peg, is employed to assess implant stability in four directions. A continuous audible signal indicated successful measurement, and the implant stability quotient (ISQ) value is displayed on the device screen. ISQ values are recorded for mesio-distal, disto-mesial, bucco-lingual, and lingo-buccal directions. The scale is numbered from 0 to 100. The higher the implant stability quotient (ISQ) values, the more stable the implant. • Secondary implant stability is measured following new bone development around the implant's surface over time, biological fixation of the implants to the surrounding bone develops.	at baseline, after 6 months, and after 12 months.
Marginal bone loss	Evaluation of the buccal bone level (BBL), palatal bone level (PBL) or lingual bone level (LBL), mesial bone level (MBL), and distal bone level (DBL) is performed with two views, coronal and sagittal, are utilized in the determination of mesial and distal and buccal and palatal / lingual marginal bone levels around the implant, respectively.	at baseline, after 6 months, and after 12 months
Bone density Recording	Bone density is assessed in terms of Hounsfield unit (HU) in pre-operative and 3 months post-operative CBCT scans. The quality of bone is grouped into D1, D2, D3, and D4 types of bone. Bone density is recorded from the sagittal view. The total length of the implant is measured and then divided into three parts, representing the coronal, middle, and apical thirds, and the readings are recorded from the mesial and distal aspects of the fixture. Measurements are taken from around approximately 2 mm in a parallel manner away from the implant fixture. Then, those six readings are divided by 6 to get the mean value of bone density around each implant.	at baseline, after 6 months, and after 12 months

Collaborators and Investigators

• Sponsor: Sana'a University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: June 15, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Short Dental Implant

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: I am committed to maintain the complete confidentiality of the data, information, and identity of all participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No