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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02996370
Enrollment
12
Registered
2016-12-19
Start date
2010-10-31
Completion date
2011-09-30
Last updated
2016-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Loss, Bone Loss

Keywords

esthetic, inter-implant papilla, soft tissue tickness, crestal bone loss, second stage surgery

Brief 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.

Detailed 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.

Interventions

OTHERpapilla 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 was measured on digital radiographs at baseline, 3 and 6 month with a Java program me (Image-J 3.0 NIH, Bethesda, USA)

The change of probing depth between baseline, 3 and 6month. Probing depth was measured with a plastic periodontal probe (mm)

OTHERModified 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.

OTHERModified plaque index

Modified plaque index was measured baseline, 3 and 6 month. Presence of plaque index was performed at four sites of implants.

Sponsors

Ege University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
papilla fill indexbaselineBaseline will be 1 week after cementation of the crowns.
crestal bone lossChange from baseline crestal bone level up to 3 monthsCrestal bone loss was measured on radiographs between baseline-3rd month.
vertical distancebaseline, 3 and 6 monthInter-implant vertical distance between the crests top-contact point was also evaluated with digital periapical radiographs.

Secondary

MeasureTime frameDescription
Probing depthbaselineThe level of probing depth at baseline. Probing depth was measured with a plastic periodontal probe.
Keratinized tissue levelKeratinized tissue level was recorded at baselineKeratinized tissue level measured with a plastic periodontal probe
Modified sulcus bleeding indexModified sulcus bleeding index was recorded at baselineModified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.
Modified plaque indexModified plaque index was recorded at baselineThe dichotomous presence of supra gingival plaque was recorded at four sites of implants

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026