Novel Soft Tissue Augmentation Technique Using Free Gingival Graft Simultaneous With Posterior Mandibular Implant

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorMisr International University

About this trial

Presence of keratinized tissue (KT) around dental implants, plays a crucial role in stability and health of peri-implant tissues. Several studies reported that, minimum of 2 mm keratinized tissue width is required to achieve long-term longevity. Insufficient keratinized mucosa leads to biofilm accumulation, soft tissue inflammation, eventually peri-implant mucositis and peri-implantitis. Hence, the aim of the present trial is to evaluate KTW gain, linear and volumetric changes in buccal soft tissue along with hard tissue alterations following implant restoration at sites treated either with delayed implant placement \& simultaneous FGG or the conventional FGG protocol prior to implant placement.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults at or above the age of 18.

Lower Posterior missing tooth/ teeth with minimal KT < 2mm

Sufficient alveolar ridge length minimum 13-15 mm to IAN

Patients able to tolerate surgical periodontal procedures.

Disqualifiers

Patients diagnosed with periodontal diseases (Caton et al., 2018).

Current or previous smokers.

Pregnant and lactating females.

Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking intravenous Bisphosphonates for treatment of osteoporosis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • One Step Protocol

    Procedure/Surgery

    FGG will be done simultaneous with implant placement

  • Two Steps Protocol

    Procedure/Surgery

    Conventional FGG protocol, prior to implant placement

Treatment groups

22 Participants
are divided into 2 treatment groups
Group A: One Step ProtocolExperimental treatment 1 intervention
Group B: Two Steps protocolActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Keratinized tissue width

Measure Clinically and Digitally at 0 - 3 - 6 - 12 months postoperative

Time frame
0 - 3 - 6 - 12 months

Secondary outcomes

1

Linear changes in buccal soft tissue contour

Time frame
0-3, 0-6, 0-12 Months
2

Interdental Papilla height changes

Time frame
12 months
3

Midfacial margin changes

Time frame
12 Months
4

Crestal bone level changes

Time frame
12 Months

Other outcomes

Sponsors and contacts

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

Misr International University

Lead sponsor

International Dental Contiuing Education

Sponsor institution

International Dental Contiuing Education

Collaborator