Evaluation of Immediate Implant Placement Using Dual Zone Approach Versus Connective Tissue Graft

Immediate Dental Implants Clinical Trial

Official title:

Clinical and Radiographic Evaluation of Immediate Implant Placement Using Dual Zone Approach Versus Connective Tissue Graft: A Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05776498
• Other study ID #: IDCE.N3
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: August 2023

Study information

• Verified date: June 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Tooth extraction is followed by ridge alteration and soft tissue collapse and recession. Different strategies were proposed to limit this collapse however, the ability of these techniques to mimic the original soft tissue level and to maintain long term stability is unclear (Slagter et al., 2014). Using customized contoured healing abutments at the time of immediate implant placement is a treatment modality to improve esthetics by maintaining the soft tissue level and contour (Ruales-Carrera et al, 2019, Perez et al, 2020). Using connective tissue grafts has been suggested to enhance and maintain soft tissue stability, however, the effect of the combined procedures for maintenance of the soft tissue morphology compared to customized healing abutments alone remains unclear (Atieh et al, 2019). In patients with non-restorable teeth in the esthetic zone, will the use of bone grafts to the dual zone with customized healing abutment vs the use of connective tissue graft with customized healing abutment in immediately placed implants shows better buccal contour avoiding horizontal collapse?

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: August 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria:

Patient-related criteria:

• Adults at or above the age of 18.

• Non-restorable maxillary anterior or premolar tooth requiring extraction and needed an implant placing therapy.

• The failing tooth will have adjacent and opposing natural teeth.

• Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration.

• Able to tolerate surgical periodontal procedures.

• Full mouth plaque and bleeding scores less than 20%.

• Compliance with the maintenance program.

• Provide informed consent.

• Accepts the one-year follow-up period.

Teeth related criteria:

• Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.

• Intact socket wall before the extraction, buccal bone thickness =1mm assessed by CBCT.

• Sufficient apical bone to place an immediate implant with minimum primary stability of 30Ncm.

Exclusion criteria:

• Patients diagnosed with periodontal diseases.

• Current or previous smokers.

• Pregnant and lactating females.

• Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking IV Bis-phosphonates for treatment of osteoporosis.

• Patients with active infection related at the site of implant/bone graft placement.

• Patients with parafunctional habits

Related Conditions & MeSH terms

• Immediate Dental Implants

Intervention

Procedure:
• immediate implant placement with particulate bone graft using the dual zone technique.
Tooth extraction and immediate implant placement as mentioned, then particulate bone graft will be packed in the gap between the implant and the buccal plate of bone and the tissue (dual zone), then will be covered by a customized healing abutment.
• immediate implant placement with connective tissue grafting
Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supraperiosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment.

Locations

Country	Name	City	State
Egypt	International Dental Continuing Education	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pink esthetic score (PES)	To evaluate the pink esthetic score 1-14 score	3 months after crown placement
Secondary	Volumetric analysis of buccal contour	3D viewer soft tissue; mm changes in the buccal soft tissue contour in comparison to the original ones, at 2,4 and 6 mm from the pre-operative gingival margin	6 months
Secondary	Mid-facial recession	3D viewer soft tissue	1 year
Secondary	Interdental papilla	3D viewer soft tissue	1 year
Secondary	Horizontal labio-palatal bone width	CBCT cone beam CT	1 year
Secondary	Bone formed labial to the implant	CBCT cone beam CT	1 year
Secondary	gingival biotype	thickness in millimeters mm	1 year