Effect of I-Shape Incısıon Technique on Inter-Implant Papilla: A Prospective Randomized Clinical Trial

Bone Loss Clinical Trial

Official title:

Effect of I-Shape Incısıon Technique on Inter-Implant Papilla: A Prospective Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02996370
• Other study ID #: EGE-OP 2013
• Status: Completed
• Phase: N/A
• First received: December 8, 2016
• Last updated: December 14, 2016
• Start date: October 2010
• Est. completion date: September 2011

Study information

• Verified date: December 2016
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Regenerating a predictable inter-implant papilla is the most complex and challenging aspect of implant dentistry. The aim of the study was to compare the efficacy of I shaped incision technique and conventional midcrestal incision technique for interimplant papilla reconstruction in a 6 month clinical trial.

Description:

A total of 40 implants were placed in 12 patients. Groups were determined at second stage surgery, I shape technique used in test group and mid-crestal technique used in control group. The clinical parameters, including modified plaque index, modified sulcus bleeding index, probing depth, keratinized tissue level were recorded baseline, 3 and 6 month. The vertical distance between the crests top-contact point was evaluated with digital periapical radiographs at baseline 3 and 6 month. Also the clinical photographs were taken baseline, 3 and 6 month. Two T shaped full-round hexagonal straight filaments, each 5 mm, were used in the taking of standardized images. With these images the ratio of the papilla area in proportion to the embrasure area and the papilla classification was measured. Non-parametric test were used for statistically analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• No sistemic condition, and age > 18 years,

• healthy soft tissue (bleeding on probing (BOP) = 20%, Plaque Index = 15%,

• in a need of at least two collateral implants in the maxilla from second premolar to second premolar

• sufficient keratinized tissue

• no bone augmentation procedures before implant placement

• use of tobacco 10N = cigarettes daily

• sufficient distance between opposite occluding dentition at the proposed implant sites

Exclusion Criteria:

• history of aggressive periodontitis,

• systemic diseases such as diabetes

• pregnant or lactating women

• radiation therapy in the head and neck area wihtin the previous 12 months,

• heavy smokers

• bruxism.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Loss
• Tooth Loss

Intervention

Other:
• papilla fill index
The clinical photographs were taken baseline, 3 and 6 month. Two T shaped full-round hexagonal straight filaments, each 5 mm, were used in the taking of standardized images.
• crestal bone loss
Crestal bone loss was measured on digital radiographs at baseline, 3 and 6 month with a Java program me (Image-J 3.0 NIH, Bethesda, USA)
• probing depth
The change of probing depth between baseline, 3 and 6month. Probing depth was measured with a plastic periodontal probe (mm)
• Modified sulcus bleeding index
Modified bleeding index was measured baseline, 3 and 6 month. Presence of bleeding on probing were performed at four sites of implants.
• Modified plaque index
Modified plaque index was measured baseline, 3 and 6 month. Presence of plaque index was performed at four sites of implants.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	papilla fill index	Baseline will be 1 week after cementation of the crowns.	baseline	Yes
Primary	papilla fill index	Papilla fill index will be recorded 3rd month after baseline	3 month	Yes
Primary	papilla fill index	Papilla fill index will be recorded 6th month after baseline	6 month	Yes
Primary	crestal bone loss	Crestal bone loss was measured on radiographs between baseline-3rd month.	Change from baseline crestal bone level up to 3 months	Yes
Primary	crestal bone loss	Crestal bone loss was measured on radiographs between baseline-6th month.	Change from baseline crestal bone level up to 6 months	Yes
Primary	vertical distance	Inter-implant vertical distance between the crests top-contact point was also evaluated with digital periapical radiographs.	baseline, 3 and 6 month	Yes
Secondary	Probing depth	The level of probing depth at baseline. Probing depth was measured with a plastic periodontal probe.	baseline	Yes
Secondary	Probing depth	The level of probing depth at 3 month. Probing depth was measured with a plastic periodontal probe.	3 month	Yes
Secondary	Probing depth	The level of probing depth at 6 month. Probing depth was measured with a plastic periodontal probe.	6 month	Yes
Secondary	Modified sulcus bleeding index	Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.	Modified sulcus bleeding index was recorded at baseline	Yes
Secondary	Modified sulcus bleeding index	Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.	Modified sulcus bleeding index was recorded at 3 month	Yes
Secondary	Modified sulcus bleeding index	Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.	Modified sulcus bleeding index was recorded at 6 month	Yes
Secondary	Modified plaque index	The dichotomous presence of supra gingival plaque was recorded at four sites of implants	Modified plaque index was recorded at baseline	Yes
Secondary	Modified plaque index	The dichotomous presence of supra gingival plaque was recorded at four sites of implants	Modified plaque index was recorded at 3 month	Yes
Secondary	Modified plaque index	The dichotomous presence of supra gingival plaque was recorded at four sites of implants	Modified plaque index was recorded at 6 month	Yes
Secondary	Keratinized tissue level	Keratinized tissue level measured with a plastic periodontal probe	Keratinized tissue level was recorded at baseline	Yes
Secondary	Keratinized tissue level	Keratinized tissue level measured with a plastic periodontal probe	Keratinized tissue level was recorded at 3 month	Yes
Secondary	Keratinized tissue level	Keratinized tissue level measured with a plastic periodontal probe	Keratinized tissue level was recorded at 6 month	Yes