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Erythropoietin - Albumin Platelet-rich Fibrin in Transcrestal Sinus Lifting With Simultaneous Implant Placement

ConditionSinus Lifting
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorAlexandria University

About this trial

Background: Dental implant therapy in the posterior maxilla may be difficult owing to limited bone height after dental extraction with sinus pneumatization. Several approaches for sinus floor elevation have been documented, and hence trans crestal sinus lifting with albumin platelet rich plasma.

Aim of the study: To compare between erythropoietin and albumin platelet rich fibrin transcrestal sinus lifting versus albumin platelet rich fibrin transcrestal sinus lifting using piezoelectric device in patients with atrophic maxilla.

Methods: This study will be carried out as a randomized

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Residual bone height not less than 5 mm measured from crestal bone to sinus floor.

Both genders.

Good oral hygiene

No previous surgery or radiation treatment on the maxillary sinus

Disqualifiers

Recent radiation therapy in maxilla.

Uncontrolled systemic diseases such as diabetes mellitus.

Heavy smoker (those who smoke ≥ 25 cigarettes a day).

Alcohol abuse.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Erythropoietin and albumin PRF gel + implant placement

    Other intervention

    This group will be treated by transcrestal sinus lifting with erythropoietin and albumin PRF gel with simultaneous implant placement.

  • Albumin PRF gel +implant placement

    Other intervention

    This group (the Control group) will be treated with transcrestal sinus lifting using albumin PRF gel, with simultaneous implant placement.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Erythropoietin and albumin PRF gelExperimental treatment 1 intervention
Group B: albumin PRF gelActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in pain scores

pain will be assessed through a 10 point visual analogue scale (VAS). (0-1=none, 2-4=mild, 5-7=moderate, 8-10=severe).

Time frame
up to 14 days
2

Change in edema

Edema will be assessed as follows: 1. None (no swelling) 2. Mild (intraoral swelling confined to the surgical field) 3. Moderate (extra oral swelling in the surgical zone) 4. Severe (extraoral swelling spreading beyond the surgical zone)

Time frame
up to 14 days
3

Change in implant stability

implant stability will be assessed using ostell device

Time frame
immediate and 4 months

Secondary outcomes

1

Change in bone gain

amount of sinus bone gain (SBG) which equals implant protrusion length (IPL) added to Peri-implant sinus bone level (PSBL) which is the distance between the apex of the implant and sinus bone level

Time frame
baseline and 4 months
2

Change in bone density

it will be assessed using CBCT

Time frame
baseline and 4 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexandria University

Lead sponsor

Source ClinicalTrials.gov
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