Clinical trial NCT05381467: Evaluation of Immediate Implant Placement In The Esthetic Zone Using the Bone Shielding Concept Versus Dual Zone Therapy
Official title: The Bone Shielding Versus Dual Zone Concept in Treating Thin Walled Fresh Extraction Sockets With Immediate Implant Placement Soft and Hard Tissue Changes A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immediate Implants
Alveolar Bone Loss
Dual Zone Technique
the Bone Shielding Concept
Esthetic Zone
Keywords: esthetic zone
soft tissue augmentation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Immediate implant placement has proven to be a successful treatment procedure that is preferred by patients because of being less traumatic, more time-efficient. Nowadays, the main goal of a successful immediate implant treatment has ceased to be gaining stability and osseointegration, but achieving long-term dimensional stability has become the optimal challenge. Various soft tissue and hard tissue augmentation techniques have been investigated in order to maintain the ridge dimensions following extraction and immediate implant placement.

Detailed description: It has been noted that the different augmentation procedures aid in decreasing the dimensional changes occurring after immediate implant placement in the esthetic zone. Even though immediate implant placement is a predictable procedure, however, labial bone resorption following tooth extraction is inevitable. The available surgical techniques present do not entirely prevent dimensional variations of the peri-implant hard and soft tissues over time. Furthermore, substantial evidence showed that immediate implant placement failed to halt the resorption of the thin buccal bony plate with subsequent gingival recession, particularly in patients with thin gingival phenotype

Eligibility criteria: Inclusion Criteria:

* adult (\>18 years) patients having a single non-adjacent hopeless maxillary tooth in the esthetic zone
* type I socket (intact but thin labial plate of bone and intact overlying soft tissues)
* adequate palatal bone
* ≥3 mm apical bone to engage the immediately placed implants
* optimum primary stability (a minimum of 30 Ncm insertion torque) following tooth extraction.

Exclusion Criteria:

* smokers
* pregnant women
* patients with systemic diseases
* periodontal disease, gingival recession
* infected sockets
* periapical pathosis and history of chemotherapy or radiotherapy within the past 2 years.

Primary outcomes:
measure: Pink Esthetic Score
timeFrame: 6 months
Secondary outcomes:
measure: labial bone thickness
timeFrame: 6 months
measure: Peri-implant probing depth
timeFrame: 6 months
measure: Implant failure
timeFrame: 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: ElAskary dental center
Study officials:
affiliation: private practice, Alexandria, Egypt
name: Abdelsalam El Askary
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor in the department of oral Medicine & Periodontology, Cairo University
name: Noha A Ghallab, PhD
role: STUDY_CHAIR
affiliation: Lecturer in the department of oral Medicine & Periodontology, Cairo University
name: Nesma M shemais, PhD
role: STUDY_DIRECTOR
References: