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Effectiveness of Connective Tissue Graft With and Without Leukocyte Platelet Rich Fibrin on Peri-implant Soft Tissue Thickness Around Delayed Implants in Patients With Thin Gingival Phenotype: A Randomized Controlled Clinical Trial

ConditionSoft Tissue Thickness Around Delayed Implants in Patients With Thin Gingival Phenotype
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorBritish University In Egypt

About this trial

A stable soft and hard tissues around Osseo-integrated implants are very crucial. Soft tissue thickness around implants is crucial as it prevents peri-implant bone loss and enhance the esthetic outcomes. The treatment of thin tissue phenotype should be improved as the thin tissue phenotype will lead to plaque accumulation. There are some techniques that can increase the thickness of the peri-implant mucosa including connective tissue graft, platelet- rich fibrin and xenogeneic collagen matrix .Leukocyte and Platelet rich fibrin is a second generation platelet concentrate that was introduced by choukroun et al in 2001 after platelet rich plasma. PRF is the first source of autogenous blood derived growth factors harvested without the use of anticoagulants5. It contains various growth factors that are believed to contribute to periodontal regeneration. It promotes neovascularization and accelerated wound closing

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

1. Patients between 18-60 years. 2. With thin gingival phenotype with a peri-implant mucosal thickness of less than 2mm28. With single missing tooth in the incisor, canine and premolar area. With the presence of two natural adjacent teeth and to not have a bone augmentation procedure before or during the dental implant.

Disqualifiers

1. Smokers 2. Psychological problem 3. Pregnancy 4. Systemic disease 5. Poor oral hygiene 6. Patients who previously received radiation therapy of the jaws 7. Patients taking medications that affect healing.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Connective tissue graft(CTG)

    Procedure/Surgery

    A harvested connective tissue graft will be placed in the prepared muco-periosteal flap around the implant. The graft will be adapted and secured in place using horizontal matrices.

  • Connective tissue graft (CTG) + leukocyte platelet-rich fibrin (L-PRF)

    Procedure/Surgery

    To prepare the L-PRF, a 10 ml of blood will be drawn from the antecubital vein of the patient's right or left arm and will be transferred to the free anticoagulant test-tube. The blood sample will be immediately centrifuged at 2700 rpm for 12 minutes33. L-PRF will be applied over the connective tissue graft in the prepared mucoperiosteal flap around the implant34. Then the graft will be secured with horizontal mattresses with an absorbable vicryl 6-0. A non-absorbable prolene suture will be used to approximate the flap.

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: Control groupOther 1 intervention
Group B: Test groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Gingival thickness

Anesthetic needle with a rubber stopper36 Numerical (mm)

Time frame
6 months

Secondary outcomes

1

Postoperative pain (direct)

Visual analogue scale.

Time frame
14 days
2

Width of keratinized mucosa

Graduated periodontal probe

Time frame
6 months

Other outcomes

Sponsors and contacts

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

British University In Egypt

Lead sponsor

Source ClinicalTrials.gov
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