Clinical and Radiographic Assessment of the Outcomes of Dental Implant Inserted After Xenograft Socket Preservation in Posterior Maxilla

NCT07001813 | Completed DMC

• 1 other identifier: 545/2022
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical and Radiographic Assessment of the Outcomes of Dental Implant Inserted after Xenograft Socket Preservation in Posterior Maxilla: A Randomized Controlled Study

Conditions

Implant Therapy

Keywords

Implant; clinical stability; radiographic assessment; soft tissue health

Outcome Measures

Primary Outcomes (2)

• clinical assessment of primary stability of dental implant

  implant stability assessment by 1. rachet insertion torque * The implant was installed into the osteotomy site using the motorized method with the engine set at 50 rpm and 35-50 N/cm torque. * A ratchet was used to place the implant to the desired depth when the insertion torque was more than 35N/cm torque. 2. osstell device (ISQ) Make it possible to monitor osseointegration in a precise and objective manner. * Osstell helps to objectively and non-invasively determine implant stability. The prob attached to the instrument via a cable and measurements are displayed on the black lit display. * The device held in a right angle to the center toward the implant to be examined, the maximum deviation angle from the orthoradial direction of percussion is 45 degrees. In addition, the rod and the test surface must maintain 0.6-2.5 mm distance according to the operating instructions. * The implant stability using OSTELL device was taken immediately postoperative and was assessed after 4 months

  immediately and after four months • A ratchet was used to place the implant immediately The implant stability using OSTELL device was taken immediately postoperative implant insertion and was assessed after 4 months before prothesis

• radiographic assessment of implant stability

  1. Pre-operative radiographic evaluation: After a healing period of four months, all the patients evaluated by Scanora 3D Cone Beam Computed Tomography scanner (CBCT) for evaluation bucco-lingual dimention, mesio-distal width, relation to neighbouring vital structures, bone density and assessment good position for implant placement. Post-operative Digital Radiography Assessment: 2. Intra oral paralleling periapical direct digital radiographic procedure: Indirect Standardized digital radiographs were achieved using KaVo Scan eXam™M One and the Rinn extension cone paralleling (XCP) periapical film holder. The KaVo Scan eXam™M One is an Intraoral digital imaging plate system (psp) system using Imaging plate which is a film-like thin, flexible, and wireless phosphorescent plate, which works as a wireless receptor.

  1.Pre-operative radiographic evaluation: before implant placement 2.Intra oral paralleling periapical direct digital radiographic procedure: immediately after placement and after four months

Study Arms (2)

socket preserved

ACTIVE COMPARATOR

(8 cases): was treated by immediate socket preservation with S1-XB xenograft augmentation after extraction.

Device: socket preserved

non preserved sockets

PLACEBO COMPARATOR

(8 cases): was not exposed to any type of socket preservation after the extraction procedure.

Device: non preserved socket

Interventions

socket preserved DEVICE

(8 cases): was treated by immediate socket preservation with S1-XB xenograft augmentation after extraction.

socket preserved

non preserved socket DEVICE

(8 cases): was not exposed to any type of socket preservation after the extraction procedure.

non preserved sockets

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: males with general good health.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male patients aged between 21 and 40 years.
• General good health.
• Absence of any relevant systemic disease.
• Presence of a hopeless maxillary posterior tooth that requires extraction.
• Extraction site suitable for replacement by a dental implant.
• Cases have adequate bone width and length.
• Volunteer subjects must sign an informed consent.

You may not qualify if:

• Poor oral hygiene with no possibility of improvement.
• Smokers (more than 10 cigarettes per day).
• Chronic treatment with any medication known to affect oral status and bone turnover.
• Drug or alcohol abuse.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

faculty of dentistry Suez canal university

Ismailia, Egypt

Location

Related Publications (1)

• AAl MA, El Far M, Sheta NM, Fayyad A, El Desouky E, Nabi NA, Ibrahim M. Correlation of Implant Stability Between Two Noninvasive Methods Using Submerged and Nonsubmerged Healing Protocols: A Randomized Clinical Trial. J Oral Implantol. 2020 Dec 1;46(6):571-579. doi: 10.1563/aaid-joi-D-19-00130.

  PMID: 33494103 BACKGROUND

Study Officials

• mohamed kamel Attia, postgraduate student

  Suez Canal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study was conducted on adults above the age of 21 years old with badly decayed posterior maxillary teeth (16 cases) requiring extraction, then subjected to implant placement. These patients were divided equally and http://www.randomizer.org randomly into two groups using Group (A) (8 cases): was treated by immediate socket preservation with S1-XB xenograft augmentation after extraction. Group (B) (8 cases): was not exposed to any type of socket preservation after the extraction procedure.

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: June 3, 2025
• Study Start: August 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

EG (1)