Evaluation of Immediate Implant Placement Using Dual Zone Approach or Filling the Buccal Gap Versus Connective Tissue Graft

Sponsor

Cairo University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05776498

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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 or filling the buccal gap 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?

Condition or Disease	Intervention/Treatment	Phase
Immediate Dental Implants	Procedure: immediate implant placement with particulate bone graft using the dual zone technique. Procedure: immediate implant placement with connective tissue grafting Procedure: immediate implant placement with particulate bone graft till the bone crest	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: immediate implant placement with particulate bone graft using the dual zone technique. immediate implant placement with particulate bone graft using the dual zone technique.	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.
Experimental: immediate implant placement with connective tissue grafting immediate implant placement with connective tissue grafting	Procedure: 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.
Active Comparator: immediate implant placement with particulate bone graft till the bone crest immediate implant placement with particulate bone graft till the bone crest	Procedure: immediate implant placement with particulate bone graft till the bone crest After atraumatic extraction, immediate implant of suitable size will be placed using standard implant system protocol Placement of the implant without any raising of the flap will be performed in the correct implant position. Primary stability of the implant will be measured by rotational insertion torque value, to be ≥30Ncm. After then, the temporary cylindrical abutment will be screwed to the implant and then flowable composite will be injected to adapt to the abutment that will be sand-blasted previously for mechanical retention of the composite, taking the shape of the socket at the marginal gingiva. Particulate bone grafts will be packed in the gap between the implant and the buccal plate of bone till the crest level, then will be covered by a customized healing abutment that will be done as mentioned before but will only seal the socket without extending deeper apically in the soft tissue. The custom healing screw will then be screwed to the implant with the correct torque.

Arm

Intervention/Treatment

Experimental: immediate implant placement with particulate bone graft using the dual zone technique.

immediate implant placement with particulate bone graft using the dual zone technique.

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.

Experimental: immediate implant placement with connective tissue grafting

immediate implant placement with connective tissue grafting

Procedure: 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.

Active Comparator: immediate implant placement with particulate bone graft till the bone crest

immediate implant placement with particulate bone graft till the bone crest

Procedure: immediate implant placement with particulate bone graft till the bone crest

After atraumatic extraction, immediate implant of suitable size will be placed using standard implant system protocol Placement of the implant without any raising of the flap will be performed in the correct implant position. Primary stability of the implant will be measured by rotational insertion torque value, to be ≥30Ncm. After then, the temporary cylindrical abutment will be screwed to the implant and then flowable composite will be injected to adapt to the abutment that will be sand-blasted previously for mechanical retention of the composite, taking the shape of the socket at the marginal gingiva. Particulate bone grafts will be packed in the gap between the implant and the buccal plate of bone till the crest level, then will be covered by a customized healing abutment that will be done as mentioned before but will only seal the socket without extending deeper apically in the soft tissue. The custom healing screw will then be screwed to the implant with the correct torque.

Outcome Measures

Primary Outcome Measures

pink esthetic score (PES) [3 months after crown placement]
To evaluate the pink esthetic score 1-14 score

Secondary Outcome Measures

Volumetric analysis of buccal contour [6 months]
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
Mid-facial recession [1 year]
3D viewer soft tissue
Interdental papilla [1 year]
3D viewer soft tissue
Horizontal labio-palatal bone width [1 year]
CBCT cone beam CT
Bone formed labial to the implant [1 year]
CBCT cone beam CT
gingival biotype [1 year]
thickness in millimeters mm

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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