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NCT Number: NCT05990283

Socket Shield Technique and Guided Bone Regeneration

Among the individuals who applied to the Department of Periodontology, Faculty of Dentistry, Health Sciences University between 2019 and 2021, patients with an unrestorable tooth in the maxillary esthetic region and required implant placement were included in this randomized clinical trial. Before implant surgery, patients were randomized into socket shield technique and guided bone regeneration groups. While the buccal gap was untreated in the socket shield group, a xenograft, and membrane were applied in the regeneration group. Peri-implant pocket depth, modified plaque index, modified bleeding index, keratinized mucosa width, and mucosal thickness were recorded at the permanent restoration and the postoperative first year. Horizontal bone level and vertical bone level were assessed with cone beam computed tomography images taken before the surgery and one year after prosthesis insertion. The pink esthetic score was evaluated with intraoral photographs taken before the surgical procedure and first-year follow-up.

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Key information

Conditions

Immediate Implant Placement

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kutahya Health Sciences University

Kütahya, 43100, Turkey (Türkiye)

About this study

This study aimed to compare the non-grafted socket shield technique with simultaneously guided bone regeneration in immediate implant placement in terms of clinical, esthetic, and radiographic parameters. Within the scope, immediate implant placement was applied to randomized groups (socket shield technique and guided bone regeneration). Immediate implant placement was performed following shield preparation in the shield group, and guided bone regeneration was applied in the regeneration group. A temporary non-functional immediate prosthesis was inserted at the same visit. After four months, permanent restorations were applied. Clinical, radiographic, and esthetic parameters were compared between two groups at baseline and first-year follow-up.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with the health status of American Society of Anesthesiologists class I or II,
  • Nonsmokers,
  • Unrestorable single-rooted tooth in the maxillary esthetic region,
  • Periodontally healthy, non-mobile teeth,
  • Single implant placement,
  • Minimum 3-5 mm available vertical bone apical to the apex,
  • Intact socket wall after extraction.

Exclusion criteria

  • Medically compromised patients, especially uncontrolled diabetes,
  • Psychiatric problems,
  • Pregnancy, lactation, or suspicion of pregnancy,
  • A history of radiation therapy to the head and neck region or immunosuppressive therapy,
  • Metabolic bone disorder or the presence of drugs known to affect bone metabolism,
  • Poor plaque control,
  • Vertical root fracture on the buccal surface or a horizontal fracture below the bone level,
  • External or internal resorption affecting the buccal part of the root,
  • Acute infection in the area intended for implant placement,
  • Refusal to attend follow-up appointments.

Treatment and study plan

Socket Shield Technique

Procedure

For the patients in the shield group, shields were prepared with the Root Membrane Kit. After the palatal part was removed, the buccal fragment was prepared at the crest level, and an internal bevel chamfer was formed on the fragment. Implants were placed 3-4 mm apical to the gingival margin of the adjacent teeth. Healing caps were placed, and the periphery of the caps was covered with an absorbable gelatin sponge.

Guided bone regeneration

Procedure

For the patients in the regeneration group, teeth were extracted atraumatically, implants were placed 3-4 mm to the gingival margin, and the space between the implant and buccal bone was filled with anorganic bovine bone graft at the time of implant placement. The graft particles were covered by a pericardium membrane. The membrane was fixed to the bone with titanium pins.

Primary outcomes

  1. Peri-implant probing depth

    Time frame: Four months after implant restoration and first-year follow-up

    Probing depth measured by Williams periodontal probe

  2. Modified plaque index

    Time frame: Four months after implant restoration and first-year follow-up

    An index evaluated by the Williams periodontal probe indicates a minimum of 0 and a maximum of 3, with higher values indicating a worse outcome

  3. Modified bleeding index

    Time frame: Four months after implant restoration and first-year follow-up

    An index evaluated by the Williams periodontal probe indicates a minimum of 0 and a maximum of 3, with higher values indicating a worse outcome

  4. Keratinized mucosa width

    Time frame: Four months after implant restoration and first-year follow-up

    The distance from the peri-implant mucosa margin to the mucogingival junction

  5. Mucosal thickness

    Time frame: Four months after implant restoration and first-year follow-up

    The thickness measured at 1.5 mm from the margin by the endodontic spreader

  6. Radiographic bone level in the horizontal dimension

    Time frame: Before implant surgery and first year follow-up

    Horizontal bone level measured at cone beam computed tomography images

  7. Radiographic bone level in the vertical dimension

    Time frame: Before implant surgery and first year follow-up

    Vertical bone level measured at cone beam computed tomography images

  8. Pink esthetic score

    Time frame: Before implant surgery and first year follow-up

    A score as assessed by intraoral photographs, showing a minimum of 0 and a maximum of 14, with higher values indicating a better esthetic result

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

Comparison of Non-grafted Socket Shield Technique With Guided Bone Regeneration in Immediate Implant Placement

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Aug 14, 2023
Registry last updated
Aug 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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