Subepithelial Connective Tissue Graft Versus Socket Shield Technique In Immediately Placed Implants

Mansoura University

Status: Completed

Conditions: Immediate Implants

Treatments: Procedure: Classic Immediate implant; Procedure: Immediate implant combined with subepithelial connective tissue graft; Procedure: Immediate dental implant placement using socket shield technique

Study type: Interventional

Funder types: Other

Identifiers

NCT06478511

SECT / SST immediate implant

Details and patient eligibility

About

The purposes of study are:

1. To assess the efficacy of immediate implant placement in preserving hard and soft tissue around implants clinically and radiographically.
2. To assess the efficacy of immediate implant placement combined with subepithelial connective tissue graft in preserving hard and soft tissue around implants clinically and radiographically.
3. To assess the efficacy of implants installed immediately using Socket Shield Technique in preserving hard and soft tissue around implants clinically and radiographically.
4. To compare immediate implant placement versus implants installed immediately using Socket Shield Technique in preserving hard and soft tissue around implants clinically and radiographically.

Full description

Patient's selection:

Patients in this study will be selected from the outpatient clinic of Oral Medicine and Periodontology department, Faculty of Dentistry, Mansoura University.

Patients participating in this study will sign an informed consent demonstrating the purpose of this study, treatment procedure, probable risks and benefits from this treatment procedure. The study proposal will be reviewed by the faculty's Research Ethics Committee.

All the selected patients will receive full mouth scaling, preoperative periapical x-ray and cone beam computed.

Surgical procedures:

Before surgery, Preoperative antibiotics will be given orally one hour prior to surgery (amoxicillin, 2g, or clindamycin, 600 mg, for patients allergic to penicillin) the patients will be advised to rinse for one minute with chlorhexidiene mouthwash. After local anesthesia administration, In group 1, the teeth will be extracted gently using periotomes, in an attempt to preserve facial and lingual bone plates. The sockets will be debrided of soft tissue and irrigated. Then all walls of the socket will be inspected and checked for the presence of fenestration or dehiscence defects in bone. The length and width of extracted roots will be measured to determine the length and diameter of implants placed. The osteotomy sites will be prepared and the drills will be used in proper sequence according to manufacturer's instructions, with maximum use of bone apical to the extraction sockets. The drills will extend 3 to 5 mm beyond the apex of the socket to ensure primary stability after placement, taking care of the anatomical boundaries. After the osteotomy sites had been prepared, the implants will be placed.

In group 2, concerning the donor site of the connective tissue, connective tissue graft was harvested from palate using trap door technique (27) utilizing a horizontal incision 3-4 mm away from the gingival margin with two vertical incisions on the either end of the first incision, creating a door, the door is then undermined and opened using a sharp dissection, the underlying connective tissue is then harvested using a periosteal elevator, and the door was then sutured using 4 0 silk sutures Finally, the connective tissue graft was immediately placed into the recipient site after a tunneling procedure and sutured with 6-0 nonresorbable monofilament sutures.

In group 3, the crown of the involved tooth will be removed and the root will be then sectioned in a mesiodistal direction along its long axis as far apical as was possible using a long shank fissure bur coupled to a hydrated high-speed handpiece. Sectioning will divide the tooth root into facial and palatal halves with the intention of preserving the facial root section unmanipulated and attached to the tooth socket. Periotomes will be then inserted between the palatal root section and the alveolar socket wall to sever the PDL and this section of root will be then carefully delivered with so as not to disturb the facial root section.

The remaining root section will be then reduced coronally to 1 mm above the alveolar crest, and will be thinned slightly to a concave contour by careful application in an apico-coronal and mesiodistal direction with a long shanked round diamond. The tooth socket's palatal wall and apex will be then curetted to remove any tissue or infective remnants and the root section will be checked for immobility with a sharp probe. With the preparation steps complete, the tooth root hereafter will be known as the socket-shield. An osteotomy will be then sequentially prepared and internal conical connection implant was inserted palatal to the socket shield with the implant 2 mm below the facial crest.

Immediate temporary dentures were fabricated using plastic and inserted on the day of implantation. Patients were instructed to consume soft food for eight weeks. Following a healing period of 6 months, the final restorations will be delivered.

Enrollment: 33 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male/female patients, age: >18 years.
• Healthy periodontium with gingival biotype at least 2mm.
• Extraction socket with four intact walls.
• Adequate native bone to achieve good primary stability.
• No untreated carious lesions.
• Missing anterior (incisor/canine) with healthy adjacent teeth bilaterally.
• Useless broken single-tooth with only lingual root fracture caused by trauma.

Exclusion criteria

• History of systemic disease (excluding well-controlled diabetes).
• Recent infectious diseases or surgical treatment within 30 days.
• Smokers (≥10 cigarettes a day).
• Pregnancy or lactation.
• Patients on regular medications affecting periodontal healing (e.g., phenytoin, dihydropyridines, calcium antagonists, and cyclosporine) or anticoagulant therapy with warfarin, clopidogrel, ticlopidine, and aspirin.
• Presence of pathological lesions around the surgical area.
• Severe mental disorders or uncooperative patients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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33 participants in 3 patient groups

Classic immediate implant

Active Comparator group

Description:

Include 11 implants (Nucleoss T6®) , maximum two per patient, will be placed immediately after atraumatic extraction.

Treatment:

Procedure: Classic Immediate implant

Immediate implant combined with subepithelial connective tissue graft

Active Comparator group

Description:

Include 11 implants, maximum two per patient will be placed immediately after atraumatic extraction and subepithelial connective tissue graft will be harvested and placed.

Treatment:

Procedure: Immediate implant combined with subepithelial connective tissue graft

Immediate implant using socket shield technique

Active Comparator group

Description:

include 11 implants, maximum two per patient will be placed immediately using Socket Shield Technique.

Treatment:

Procedure: Immediate dental implant placement using socket shield technique