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

NCT06478511 | Completed DMC

• 1 other identifier: SECT / SST immediate implant
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of study are:

1. 1.To assess the efficacy of immediate implant placement in preserving hard and soft tissue around implants clinically and radiographically.
2. 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. 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. 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.

Conditions

Immediate Implants

Keywords

Immediate implants,Socket shield technique

Outcome Measures

Primary Outcomes (4)

• Clinical success of socket shield technique in immediate implant placement

  Implant placement using socket shield technique, including: shortened treatment time and minimizes alveolar bone loss.

  6 months

• Clinical success of socket shield technique in immediate implant placement

  Implant placement using socket shield technique, including: shortened treatment time and minimizes alveolar bone loss.

  12 months

• Clinical success of SECT graft in immediate implant placement

  Implant placement with SECT graft, including: shortened treatment time and minimizes alveolar bone loss.

  6 months

• Clinical success of SECT graft in immediate implant placement

  Implant placement with SECT graft, including: shortened treatment time and minimizes alveolar bone loss.

  12 months

Study Arms (3)

Classic immediate implant

ACTIVE COMPARATOR

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

Procedure: Classic Immediate implant

Immediate implant combined with subepithelial connective tissue graft

ACTIVE COMPARATOR

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

Procedure: Immediate implant combined with subepithelial connective tissue graft

Immediate implant using socket shield technique

ACTIVE COMPARATOR

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

Procedure: Immediate dental implant placement using socket shield technique

Interventions

Classic Immediate implant PROCEDURE

The teeth will be extracted gently using periotomes to preserve facial and lingual bone plates. 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. The implants will be placed.

Classic immediate implant

Immediate implant combined with subepithelial connective tissue graft PROCEDURE

Connective tissue graft was harvested from palate using trap door technique utilizing a horizontal incision 3-4 mm away from the gingival margin with two vertical incisions on the either end of the first incision, 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.

Immediate implant combined with subepithelial connective tissue graft

Immediate dental implant placement using socket shield technique PROCEDURE

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. Preserving the facial root section unmanipulated and attached to the tooth socket. Periotomes will be then inserted between the palatal root removed gentelly.The remaining root section will be then reduced coronally to 1 mm above the alveolar crest.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 shield with the implant 2 mm below the facial crest.

Immediate implant using socket shield technique

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistery

Al Mansurah, 35516, Egypt

Location

Related Publications (2)

• Sun C, Zhao J, Liu Z, Tan L, Huang Y, Zhao L, Tao H. Comparing conventional flap-less immediate implantation and socket-shield technique for esthetic and clinical outcomes: A randomized clinical study. Clin Oral Implants Res. 2020 Feb;31(2):181-191. doi: 10.1111/clr.13554. Epub 2019 Dec 13.

  PMID: 31680339 RESULT

• Zhang Z, Dong Y, Yang J, Xu R, Deng F. Effect of socket-shield technique on alveolar ridge soft and hard tissue in dogs. J Clin Periodontol. 2019 Feb;46(2):256-263. doi: 10.1111/jcpe.13073.

  PMID: 30661247 RESULT

Study Officials

• Samah H Elmeadawy, PhD

  Professor Of Periodontology, Faculty Of Dentistry, Mansoura University

  STUDY CHAIR

• Bassant H Elmowafey, PhD

  Professor Of Oral Radiology Faculty Of Dentistry, Mansoura University

  STUDY DIRECTOR

• Hesham Abdallah, MSc

  PhD researcher at Faculty Of Dentistry, Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD researcher in oral medicine and periodontology department

Model Details: 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. Patients will be randomly allocated to one of three groups: 1. Group 1 (control group): Will include 11 implants (Nucleoss T6®) , maximum two per patient, will be placed immediately after atraumatic extraction. 2. Group 2 : Will include 11 implants, maximum two per patient will be placed immediately after atraumatic extraction and subepithelial connective tissue graft will be harvested and placed. 3. Group 3: Will include 11 implants, maximum two per patient will be placed immediately using Socket Shield Technique. All osteotomy sites will receive Biogap® bone graft if there are gap between implant and labial bone/ buccal shield ≥ 2mm. All the selected patients will receive full mouth scaling, preoperative periapical x-ray and cone beam computed tomography.

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 27, 2024
• Study Start: December 5, 2020
• Primary Completion: September 10, 2023
• Study Completion: April 20, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)