NCT04694196

Brief Summary

Occlusal plane "the average plane established by the incisal and occlusal surfaces of the teeth -The glossary of prosthodontic terms. Generally, it is not a plane but represents the planar mean of the curvature of these surfaces". Correct orientation of the occlusal plane plays a vital role in achieving optimal aesthetics, occlusal balance and function of complete dentures. Faulty orientation of occlusal plane in fixed or removable prostheses will affect the interaction between tongue and buccinator muscle resulting in food collection in sulcus and cheek or tongue biting. The occlusal plane is normally established anteriorly according to aesthetics of patient and posteriorly parallel to camper's plane. In the mandibular arch there are few landmarks which could be used to orient the occlusal plane like the retromolar pad, commissure of the lips and lateral borders of the tongue. Various landmark have been used to orient the occlusal plane in the maxillary arch e.g. parotid papilla, hamular notch- incisive papilla plane, ala-tragus line. There is no single method seems entirely accurate to locate the occlusal plane in edentulous patients. Therefore ,Investigators need a stable anatomic landmark can be used as a guide to determine occlusal plane (OP). Material and Methods: Forty Dentulous patients will be selected. All subjects had natural maxillary and mandibular teeth. In addition all subjects exhibited Class I skeletal and dental relationships with no prosthetic dental replacement. Subjects with Claa II or Class III relationships,fractured or abraded edges of the teeth,ankyloglossia and orthodontic treatment were excluded from the study. The mandibular posterior occlusal plane was determined according to the level of coronoid notch{CN} (greatest concavity anterior border of the ramus) by measure the distance between the occlusal plane and CN.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

September 20, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

1 month

First QC Date

December 16, 2020

Last Update Submit

September 9, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Occlusal plane marker in mandible

    We will measure the occlusal plane in all forty a participants determined by a horizontal ruler to the level of Coronoid Notch(CN) at the anterior border of ramus in mandible.the measure will be in Millimetre(mm)above, under or at the level of Coronoid Notch(CN).

    Through study completion .an average one week

  • Aesthetic of complete denture in edentulous patients.

    After delivery the dentures to patients..we will examine the aesthetic effect to participants throughout examine acceptable response for the patients.

    After 1 month

Study Arms (1)

Locate occlusal plane

EXPERIMENTAL

Use anatomical landmark to locate OP in dentulous subjects.

Device: Dentulous subjects

Interventions

Determine the occlusal plane using CN in anterior border of ramus

Locate occlusal plane

Eligibility Criteria

Age21 Years - 27 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • Subjects with Claa II or Class III relationships,fractured or abraded edges of the teeth,ankyloglossia and orthodontic treatment were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fadi Jnaid

Damascus, Rif-dimashq Governorate, Syria

Location

Related Publications (9)

  • Jain R, Shigli K. An in vivo study to correlate the relationship of the extraoral and intraoral anatomical landmarks with the occlusal plane in dentulous subjects. Indian J Dent Res. 2015 Mar-Apr;26(2):136-43. doi: 10.4103/0970-9290.159138.

    PMID: 26096105BACKGROUND
  • Lundquist DO, Luther WW. Occlusal plane determination. J Prosthet Dent. 1970 May;23(5):489-98. doi: 10.1016/0022-3913(70)90198-8. No abstract available.

    PMID: 4908801BACKGROUND
  • Kazanoglu A, Unger JW. Determining the occlusal plane with the Camper's plane indicator. J Prosthet Dent. 1992 Apr;67(4):499-501. doi: 10.1016/0022-3913(92)90080-t.

    PMID: 1507133BACKGROUND
  • Al Quran FA, Hazza'a A, Al Nahass N. The position of the occlusal plane in natural and artificial dentitions as related to other craniofacial planes. J Prosthodont. 2010 Dec;19(8):601-5. doi: 10.1111/j.1532-849X.2010.00643.x. Epub 2010 Nov 11.

    PMID: 21070428BACKGROUND
  • Nissan J, Barnea E, Zeltzer C, Cardash HS. Relationship between occlusal plane determinants and craniofacial structures. J Oral Rehabil. 2003 Jun;30(6):587-91. doi: 10.1046/j.1365-2842.2003.01044.x.

    PMID: 12787455BACKGROUND
  • Tsay TP, Oyen OJ. A study of the suitability of two methods used for describing the occlusal plane. Proc Natl Sci Counc Repub China B. 1992 Jul;16(3):126-33.

    PMID: 1296213BACKGROUND
  • Karkazis HC, Polyzois GL. A study of the occlusal plane orientation in complete denture construction. J Oral Rehabil. 1987 Jul;14(4):399-404. doi: 10.1111/j.1365-2842.1987.tb00735.x.

    PMID: 3305842BACKGROUND
  • Raza M, Ayub N, Imran M, Nawaz K, Sami A. Occlusal Plane Evaluation In Dentate Patients For Complete Denture Prosthodontic Practice. J Ayub Med Coll Abbottabad. 2020 Jan-Mar;32(1):54-57.

    PMID: 32468756BACKGROUND
  • Javid NS. A technique for determination of the occlusal plane. J Prosthet Dent. 1974 Mar;31(3):270-2. doi: 10.1016/0022-3913(74)90195-4. No abstract available.

    PMID: 4521346BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: No evidence of infection or trauma in oral Negative history of TMJ disorders
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2020

First Posted

January 5, 2021

Study Start

September 20, 2021

Primary Completion

November 1, 2021

Study Completion

December 1, 2021

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations