Novel Soft Tissue Augmentation Technique Using Free Gingival Graft Simultaneous With Posterior Mandibular Implant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: One Step Protocol, Two Steps Protocol.
- Who it may be relevant to
- Registry conditions: Free Gingival Graft, Free Gingival Graft Volume Change, Keratinized Tissue. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Novel Soft Tissue Augmentation Technique Using Free Gingival Graft Simultaneous With Implant Placement in Posterior Mandible: A 1-year Randomized Clinical Trial
Overview
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.
Interventions
- Procedure One Step Protocol
FGG will be done simultaneous with implant placement - Procedure Two Steps Protocol
Conventional FGG protocol, prior to implant placement
Primary outcome measures
- Keratinized tissue width [Time frame: 0 - 3 - 6 - 12 months]
Secondary outcome measures (6)
- Linear changes in buccal soft tissue contour [Time frame: 0-3, 0-6, 0-12 Months]
- Interdental Papilla height changes [Time frame: 12 months]
- Midfacial margin changes [Time frame: 12 Months]
- Crestal bone level changes [Time frame: 12 Months]
- Bone labial to the implant [Time frame: 12 Months]
- Survival Rate [Time frame: 12 Months]
Eligibility criteria
Inclusion criteria
- 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
•. Sufficient alveolar ridge width minimum of 6 mm
- Patients able to tolerate surgical periodontal procedures.
- Patients who provided an informed consent and accepted the one-year follow-up period.
Exclusion criteria
- 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.
- Patients with active infection related to the site of implant.
- Patients with parafunctional habits.
- Patients with shallow vestibule
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- International Dental Continuing Education — Cairo
Identifiers
NCT: NCT06645925 · IDCE - 13