Implant Stability Outcomes Following Immediate Implant Placement Using Osseodensification Versus Conventional Drilling

Официальное название

Clinical, Radiographic, and Implant Stability Outcomes Following Immediate Implant Placement Using Osseodensification Versus Conventional Drilling in Mandibular Molar Extraction Sockets: A Randomized Clinical Trial

Обзор

The goal of this randomized clinical trial is to compare osseodensification and conventional drilling for immediate dental implant placement in mandibular molar extraction sockets in adults requiring extraction and implant replacement. The main questions it aims to answer are: Does osseodensification improve primary and secondary implant stability compared with conventional drilling? Does osseodensification result in better clinical and radiographic peri-implant outcomes, including marginal bone loss, peri-implant bone density, probing depth, plaque and bleeding indices, during the healing period? Researchers will compare immediate implant placement performed using osseodensification drilling with immediate implant placement performed using conventional drilling to determine whether osseodensification provides superior implant stability and peri-implant tissue outcomes. Participants will: Undergo atraumatic extraction of a mandibular molar followed by immediate implant placement. Be randomly assigned to receive implant site preparation using either osseodensification or conventional drilling. Receive the same implant system and standardized surgical and prosthetic protocols. Attend scheduled follow-up visits for clinical examinations, implant stability measurements using resonance frequency analysis (ISQ), and radiographic evaluation of marginal bone loss and peri-implant bone density during healing and after prosthetic restoration.

Подробное описание

Immediate implant placement into fresh extraction sockets has become a well-established treatment approach because it reduces treatment time, decreases the number of surgical procedures, and helps preserve hard and soft tissue architecture. Nevertheless, obtaining adequate primary implant stability in fresh mandibular molar extraction sockets remains a major clinical challenge because of socket morphology, limited interradicular bone, and variations in bone density.

Osseodensification is a non-subtractive osteotomy preparation technique that uses specially designed burs rotating in a densifying mode to preserve and compact bone around the implant osteotomy. Unlike conventional drilling, which removes bone during osteotomy preparation, osseodensification compacts autogenous bone along the osteotomy walls, potentially increasing bone density, bone-to-implant contact, and primary implant stability while promoting favorable healing.

Although promising results have been reported for osseodensification, clinical evidence directly comparing this technique with conventional drilling during immediate implant placement in mandibular molar extraction sockets remains limited. This randomized clinical trial was designed to evaluate whether osseodensification provides superior clinical, radiographic, and implant stability outcomes compared with conventional drilling.

Eligible participants requiring extraction of a mandibular molar followed by immediate implant placement were randomly allocated to one of two treatment groups:

Osseodensification group: implant osteotomy prepared using the osseodensification drilling protocol.

Conventional drilling group: implant osteotomy prepared using the manufacturer's conventional drilling sequence.

All participants underwent atraumatic tooth extraction, immediate implant placement using the same implant system, grafting of the peri-implant gap when indicated according to the study protocol, customized healing abutment placement, and standardized prosthetic rehabilitation after the healing period. Postoperative care and follow-up schedules were standardized for both groups.

Clinical evaluations included assessment of the modified plaque index, modified bleeding index, and peri-implant probing depth. Implant stability was assessed using resonance frequency analysis and expressed as the Implant Stability Quotient (ISQ). Radiographic assessments included measurements of marginal bone loss using standardized periapical radiographs and peri-implant bone density using cone-beam computed tomography (CBCT). Participants were followed according to the study schedule to evaluate implant stability, peri-implant tissue health, and radiographic bone changes during healing and after functional restoration.

The primary objective of the trial was to compare primary and secondary implant stability between osseodensification and conventional drilling. Secondary objectives included comparison of peri-implant clinical parameters, marginal bone loss, and peri-implant bone density between the two treatment groups.

Вмешательства

• Процедура Osseodensification drilling
  Implant osteotomy preparation was performed using the osseodensification drilling protocol with densifying burs rotating in densifying mode before immediate implant placement in mandibular molar extraction sockets.
• Процедура Conventional drilling
  Implant osteotomy preparation was performed using the conventional sequential drilling protocol before immediate implant placement in mandibular molar extraction

Первичные конечные точки

• Primary Implant Stability [Срок оценки: Day 0, and 3 months]

Вторичные конечные точки (6)

• Secondary Implant Stability [Срок оценки: 3 months after implant placement]
• Marginal Bone Loss (MBL) [Срок оценки: Baseline, 3 months, and 6 months after implant placement]
• Peri-implant Bone Density [Срок оценки: Baseline, 3 months, and 6 months after implant placement]
• Peri-implant Probing Depth (PPD) [Срок оценки: 3 months and 6 months after implant placement]
• Modified Plaque Index (mPI) [Срок оценки: Baseline, 3 months, and 6 months after implant placement]
• Modified Bleeding Index (mBI) [Срок оценки: Baseline, 3 months, and 6 months after implant placement]

Критерии участия

Критерии включения

Adults aged 20 years - 50 years. Patients requiring extraction of a mandibular first or second molar with immediate implant placement.

Presence of sufficient interradicular and apical bone to achieve primary implant stability following immediate implant placement.

Adequate bone dimensions to accommodate the planned dental implant without the need for extensive bone augmentation.

Good oral hygiene and willingness to comply with the study protocol and follow-up visits.

Ability to understand the study procedures and provide written informed consent.

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Критерии исключения

Uncontrolled systemic diseases or medical conditions contraindicating oral surgery or implant placement.

Pregnancy or lactation. Current smokers or tobacco users. Untreated active periodontal disease or poor oral hygiene. Acute infection or extensive pathology at the implant site that would preclude immediate implant placement.

History of radiotherapy to the head and neck region or treatment with intravenous bisphosphonates or other medications known to adversely affect bone healing.

Bruxism or parafunctional habits likely to compromise implant success. Inability or unwillingness to attend scheduled follow-up visits or comply with study requirements.

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Саудовская Аравия · 1 центр

• Dar AlUloom University, College of Dentistry — Riyadh

Идентификаторы

NCT: NCT07719764 · # 37-03-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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