Clinical Evaluation of Two Types of Transalveolar Sinus Floor Elevation

Dental Implant Clinical Trial

Official title:

Clinical Evaluation of Modified Transalveolar Sinus Floor Elevation and Osteotome Sinus Floor Elevation in Posterior Maxillae

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03445039
• Other study ID #: modified maxillary sinus lift
• Status: Recruiting
• Phase: N/A
• First received: January 25, 2018
• Last updated: February 19, 2018
• Start date: December 2, 2017
• Est. completion date: December 25, 2020

Study information

• Verified date: February 2018
• Source: Peking University
• Contact: Xu Zhao, Dr
• Phone: 086 13331169917
• Email: zhaoxu_[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Implant placement in the posterior maxilla is always troubled by the insufficient bone volume. Trans-alveolar sinus floor elevation (TSFE) has been proven a predictable surgical procedure to increase the bone height in the posterior maxilla. However, questions as the necessity of the bone grafting is necessary during the sinus lift and could the TSFE be performed when the residual bone height is below 5mm are still being debated. Besides, high-quality evidence on comparing the clinical outcome of transalveolar sinus floor elevation with osteotome and modified sinus floor elevation with crestal non-cutting drills is limited.

Methods/Design: 120 adult patients who fit the inclusion criterions are being recruited from the first clinical division, School and Hospital of Peking University (Beijing, China). All the patients are assigned into four groups according a table of random numbers. Participants receive 1) TSFE using osteotomes with bone grafting; 2) TSFE using osteotomes without bone grafting; 3) modified TSFE with bone grafting; and 4) modified TSFE without bone grafting. The clinical operators will be concealed with the assignment until the beginning of surgical procedures. In a one year follow up period, implant survival rates, complications, implant stability, bone remodeling around the implant and patient-reported outcome (visual analogue scale for intraoperative discomfort and postoperative pain) are observed and documented. The implant stability is gauged by the resonance frequency analysis for 7 times (2, 4,8,12,16,26,52 weeks). And the bone remodeling is observed and compared by CT scan.

Discussion: The result of the trial will support a better decision making in atrophy posterior maxilla when implant placement is needed. If favorable, the use of the modified TSFE would achieve as ideal outcome as the traditional TSFE but with less trauma and postoperative discomforts. Besides, whether the bone graft procedure is necessary for the TSFE will also be discussed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 25, 2020
• Est. primary completion date: December 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• patients who is more than 18 years old;

• patients have lost a single tooth or several teeth in the posterior area of the maxilla, the tooth has/have been extracted for more than three months;

• The residual bone height was between 3mm to 6mm;

• The width of the alveolar ridge could contain the implant with standard diameter;

• The general and local status of patient are suitable for implant placement and sinus floor elevation;

• The patient who is willing to sign the informed consent and to follow the experimental follow-up rules.

Exclusion Criteria:

• Uncontrolled systemic diseases as diabetes, hypertension and so on;

• Uncontrolled local diseases as periodontal disease or muco- cutaneous disease;

• Heavy smoker (more than 10 cigarettes /day)

• Patients who is suffering rhinitis, sinusitis; or rather large cyst is found in the maxillary sinus

• The bone density of the maxillary posterior region is too poor to maintain the initial stability of the implant

• The target of the implant site once received implant therapy or bone grafting

• Patient with psychogenia or incapable to understand and obey the doctors' instruction.

Related Conditions & MeSH terms

• Dental Implant
• Sinus Floor Augmentation

Intervention

Device:
• traditional TSFE
The TSFE procedure is performed by osteotomes (Straumann AG, Basel, Switzland) and mallet as the traditional ways.

Procedure:
• bone grafting materials
The bone substitute is placed into the siuns under the membrane before the implant placement

Device:
• TSFE by DASK drills
The TSFE procedure is performed by DASK(Dentium Advanced Surgical Kits) drills (Dentium, Korea), the residual cortical plate of the sinus floor is grinded by the drills.

Procedure:
• without bone grafting materials
The bone substitute will not be placed into the sinus before the implant placement.

Locations

Country	Name	City	State
China	Peking University, Hospital of stomatology, the first clinical division	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

References & Publications (8)

Caban J, Fermergård R, Abtahi J. Long-term evaluation of osteotome sinus floor elevation and simultaneous placement of implants without bone grafts: 10-Year radiographic and clinical follow-up. Clin Implant Dent Relat Res. 2017 Dec;19(6):1023-1033. doi: 1 — View Citation

French D, Nadji N, Shariati B, Hatzimanolakis P, Larjava H. Survival and Success Rates of Dental Implants Placed Using Osteotome Sinus Floor Elevation Without Added Bone Grafting: A Retrospective Study with a Follow-up of up to 10 Years. Int J Periodontics Restorative Dent. 2016;36 Suppl:s89-97. doi: 10.11607/prd.2191. — View Citation

Lozada JL, Goodacre C, Al-Ardah AJ, Garbacea A. Lateral and crestal bone planing antrostomy: a simplified surgical procedure to reduce the incidence of membrane perforation during maxillary sinus augmentation procedures. J Prosthet Dent. 2011 Mar;105(3):147-53. doi: 10.1016/S0022-3913(11)60020-6. — View Citation

Markovic A, Mišic T, Calvo-Guirado JL, Delgado-Ruíz RA, Janjic B, Abboud M. Two-Center Prospective, Randomized, Clinical, and Radiographic Study Comparing Osteotome Sinus Floor Elevation with or without Bone Graft and Simultaneous Implant Placement. Clin — View Citation

Pjetursson BE, Tan WC, Zwahlen M, Lang NP. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. J Clin Periodontol. 2008 Sep;35(8 Suppl):216-40. doi: 10.1111/j.1600-051X.2 — View Citation

Summers RB. The osteotome technique: Part 3--Less invasive methods of elevating the sinus floor. Compendium. 1994 Jun;15(6):698, 700, 702-4 passim; quiz 710. — View Citation

Tan WC, Lang NP, Zwahlen M, Pjetursson BE. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. Part II: transalveolar technique. J Clin Periodontol. 2008 Sep;35(8 Suppl): — View Citation

Tatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	implant survival rate	whether the implant has osseointegrated and functional	the implant status will be inspected and calculated at 1 year revisit
Primary	implant stability	the implant stability is gauged by the RFA( resonance frequency analysis)	2 weeks after implant placement
Primary	implant stability	the implant stability is gauged by the RFA( resonance frequency analysis)	4 weeks after the implant placement
Primary	implant stability	the implant stability is gauged by the RFA( resonance frequency analysis)	8 weeks after the implant placement
Primary	implant stability	the implant stability is gauged by the RFA( resonance frequency analysis)	12 weeks after the implant placement
Primary	implant stability	the implant stability is gauged by the RFA( resonance frequency analysis)	16 weeks after the implant placement
Primary	implant stability	the implant stability is gauged by the RFA( resonance frequency analysis)	26 weeks after the implant placement
Primary	implant stability	the implant stability is gauged by the RFA( resonance frequency analysis)	52 weeks after the implant placement
Primary	marginal bone remodeling around the implant	use CBCT to access the marginal bone changes between the 26 weeks after the implant placement and baseline (the day the implant is placed).	26 weeks after the implant placement
Primary	marginal bone remodeling around the implant	use CBCT to access the marginal bone changes between the 52 weeks after the implant placement and baseline (the day the implant is placed).	52 weeks after the implant placement
Primary	post operative pain accessed by the patient	The post operative pain is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No pain" and "worst imaginable pain". The patient will mark on the line to represent their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100.	1 day after the surgery
Primary	post operative pain accessed by the patient	The post operative pain is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No pain" and "worst imaginable pain". The patient will mark on the line to represent their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100.	2 days after the surgery
Primary	post operative pain accessed by the patient	The post operative pain is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No pain" and "worst imaginable pain". The patient will mark on the line to represent their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100.	3 days after the surgery
Primary	post operative pain accessed by the patient	The post operative pain is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No pain" and "worst imaginable pain". The patient will mark on the line to represent their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100.	4 days after the surgery
Primary	post operative pain accessed by the patient	The post operative pain is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No pain" and "worst imaginable pain". The patient will mark on the line to represent their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100.	5 days after the surgery
Primary	post operative pain accessed by the patient	The post operative pain is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No pain" and "worst imaginable pain". The patient will mark on the line to represent their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100.	6 days after the surgery
Primary	post operative pain accessed by the patient	The post operative pain is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No pain" and "worst imaginable pain". The patient will mark on the line to represent their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100.	7 days after the surgery
Primary	post operative pain accessed by the patient	The post operative pain is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No pain" and "worst imaginable pain". The patient will mark on the line to represent their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100.	14 days after the surgery
Primary	post operative swelling accessed by the patient	The post operative swelling is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No swelling" and "worst imaginable swelling". The patient will mark on the line to represent their swelling intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no swelling" anchor and the patient's mark, providing a range of scores from 0-100.	1 day after the surgery
Primary	post operative swelling accessed by the patient	The post operative swelling is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No swelling" and "worst imaginable swelling". The patient will mark on the line to represent their swelling intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no swelling" anchor and the patient's mark, providing a range of scores from 0-100.	2 days after the surgery
Primary	post operative swelling accessed by the patient	The post operative swelling is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No swelling" and "worst imaginable swelling". The patient will mark on the line to represent their swelling intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no swelling" anchor and the patient's mark, providing a range of scores from 0-100.	3 days after the surgery
Primary	post operative swelling accessed by the patient	The post operative swelling is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No swelling" and "worst imaginable swelling". The patient will mark on the line to represent their swelling intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no swelling" anchor and the patient's mark, providing a range of scores from 0-100.	4 days after the surgery
Primary	post operative swelling accessed by the patient	The post operative swelling is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No swelling" and "worst imaginable swelling". The patient will mark on the line to represent their swelling intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no swelling" anchor and the patient's mark, providing a range of scores from 0-100.	5 days after the surgery
Primary	post operative swelling accessed by the patient	The post operative swelling is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No swelling" and "worst imaginable swelling". The patient will mark on the line to represent their swelling intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no swelling" anchor and the patient's mark, providing a range of scores from 0-100.	6 days after the surgery
Primary	post operative swelling accessed by the patient	The post operative swelling is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No swelling" and "worst imaginable swelling". The patient will mark on the line to represent their swelling intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no swelling" anchor and the patient's mark, providing a range of scores from 0-100.	7 days after the surgery
Primary	post operative swelling accessed by the patient	The post operative swelling is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal "No swelling" and "worst imaginable swelling". The patient will mark on the line to represent their swelling intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no swelling" anchor and the patient's mark, providing a range of scores from 0-100.	14 days after the surgery
Secondary	sulcus bleeding around the implant	the sulcus bleeding index is used to measure whether there is bleeding when the dental prob is inserte the sulcus around the implant site	26 weeks after the implant placement
Secondary	dental plaque around the implant	measure whether there is dental plaque around the implant	26 weeks after the implant placement
Secondary	other complications	including post-operative infection, bleeding in the nostril,hematoma, stuffy nose and benign paroxysmal positional vertigo	through study completion, up to 1 year
Secondary	sulcus bleeding around the implant	the sulcus bleeding index is used to measure whether there is bleeding when the dental prob is inserte the sulcus around the implant site	52 weeks after the implant placement
Secondary	dental plaque around the implant	measure whether there is dental plaque around the implant	52 weeks after the implant placement