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Effect Alb-PRF & A-PRF in Alveolar Ridge Preservation in Diabetes Patients - A RCCT

ConditionTooth Extraction Status Nos
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong

About this trial

This study aim to investigate the effect of albumin gel- and platelet- rich fibrin(Alb-PRF) combined with advanced platelet-rich fibrin (A-PRF) on alveolar ridge preservation by comparing alveolar ridge morphometric changes (hard and soft tissue), prospects and treatment complexity for placement of prosthetically guided dental implant, early oral wound healing outcomes evaluated by the Inflammatory Proliferative Remodeling Scale, and patient reported outcome measures, in Type I/II Diabetes Mellitus patient, versus spontaneous healing

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Study Group

    Procedure/Surgery

    The tooth will be extracted automatically, tooth sectioning will be performed if necessary for multi-rooted teeth to minimize trauma. Alveolar ridge preservation with blood platelet concentrate: heat-treated albumin (Alb-PRF) and advanced platelet-rich fibrin. The experimental site will be filled with A-PRF plugs/membranes until level flushed with the level of bone. An additional Alb-PRF membrane will be tucked and inserted below the buccal and oral flap. Surgical flaps will not be raised. Soft tissue will be tunnelled and undermined for insertion of the Alb-PRF membrane. The extraction site and membranes will be stabilized by cross-mattress sutures and allowed for secondary intention healing.

  • Control Group

    Procedure/Surgery

    The tooth will be extracted automatically, tooth sectioning will be performed if necessary for multi-rooted teeth to minimize trauma. Cross mattress suture will be applied and site allowed to heal naturally.

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: Study GroupExperimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Ridge horizontal width

Ridge horizontal width changes (1mm, 3mm, 5mm apical to most coronal crest at buccal/oral) Method: CBCT

Time frame
Up to 20 weeks

Secondary outcomes

1

Ridge height

Ridge height changes (buccal and oral) Method: CBCT

Time frame
Up to 20 weeks
2

Ridge volume and profile

Changes in ridge volume and profilometric changes Method: Intraoral scan, CBCT

Time frame
Up to 20 weeks
3

Keratinized tissue width changes

Changes in keratinized tissue width Method: Periodontal probe with fixed landmarks

Time frame
Up to 20 weeks
4

Cytokines and growth factors

Changes in concentrations of cytokines and growth factors in wound fluid during early to mid-term wound healing events

Time frame
Up to 56 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

The University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: